Approved Risk Evaluation and Mitigation Strategies (REMS)

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The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

The table below provides links to currently approved individual and shared system REMS.

Information on historical and released REMS is available in downloadable: data files.

Name REMS Approved Last Updated MedGuide (MG)* Comm. Plan (CP) ETASU Imp. System (IS)
Adasuve (loxapine), aerosol, powder
NDA #022549
loxapine, 12/21/2012 10/10/2017
IS
Addyi (flibanserin), tablet
NDA #022526
flibanserin, 08/18/2015 06/16/2017
IS
Adempas (riociguat), tablet, film coated
NDA #204819
riociguat, 10/08/2013 01/17/2017
MG
IS
Afrezza (insulin human), powder, metered
NDA #022472
insulin human, 06/27/2014 04/01/2016
CP
Alosetron
Shared System REMS
alosetron,alosetron, 11/22/2016 11/22/2016
Androgel 1% (testosterone), gel
NDA #021015
testosterone, 09/18/2009 05/11/2015
MG
Androgel 1.62% (testosterone), gel
NDA #022309
testosterone, 04/29/2011 05/11/2015
MG
Aveed (testosterone undecanoate), injection
NDA #022219
testosterone undecanoate, 03/05/2014 12/09/2016
IS
Axiron (testosterone), solution
NDA #022504
testosterone, 11/23/2010 02/03/2017
MG
Blincyto (blinatumomab), kit
BLA #125557
blinatumomab, 12/03/2014 07/12/2017
CP
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS
buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate, 02/22/2013 05/23/2017
MG
IS
Bupropion (ANDA 206122) (bupropion hydrochloride), tablet, extended release
ANDA #206122
bupropion hydrochloride, 08/17/2016 08/17/2016
MG
Caprelsa (vandetanib), tablet
NDA #022405
vandetanib, 04/06/2011 05/16/2017
IS
Clozapine
Shared System REMS
clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine, 09/15/2015 09/15/2015
IS
Emtricitabine/tenofovir disoproxil fumarate
Shared System REMS
emtricitabine and tenofovir disoproxil fumarate,emtricitabine and tenofovir disoproxil fumarate, 07/16/2012 09/21/2017
Entereg (alvimopan), capsule
NDA #021775
alvimopan, 05/20/2008 06/01/2016
IS
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
Shared System REMS
buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol, 07/09/2012 05/26/2017
MG
Extraneal (icodextrin), injection, solution
NDA #021321
icodextrin, 03/09/2011 10/24/2016
MG
IS
Farydak (panobinostat), capsule
NDA #205353
panobinostat, 02/23/2015 02/23/2015
CP
Fortesta (testosterone), gel, metered
NDA #021463
testosterone, 12/29/2010 05/11/2015
MG
Gattex (teduglutide [rDNA origin]), injection, powder, for solution
NDA #203441
teduglutide [rDNA origin], 12/21/2012 03/21/2017
Iclusig (ponatinib), tablet, film coated
NDA #203469
ponatinib, 12/20/2013 11/28/2016
CP
Ionsys (fentanyl iontophoretic transdermal system), patch
NDA #021338
fentanyl iontophoretic transdermal system, 04/30/2015 03/29/2017
IS
Isotretinoin iPLEDGE
Shared System REMS
isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin, 10/22/2010 06/17/2017
MG
IS
Juxtapid (lomitapide), capsule
NDA #203858
lomitapide, 12/21/2012 03/02/2017
IS
Kymriah (tisagenlecleucel), injection, suspension
BLA #125646
tisagenlecleucel, 08/30/2017 08/30/2017
IS
Kynamro (mipomersen sodium), injection, solution
NDA #203568
mipomersen sodium, 01/29/2013 07/28/2015
IS
Lemtrada (alemtuzumab), injection, solution, concentrate
BLA #103948
alemtuzumab, 11/14/2014 04/05/2016
CP
IS
Letairis (ambrisentan), tablet, film coated
NDA #022081
ambrisentan, 05/29/2009 09/27/2017
MG
IS
Lotronex (alosetron hydrochloride), tablet
NDA #021107
alosetron hydrochloride, 09/02/2010 04/29/2016
Mifeprex (mifepristone), tablet
NDA #020687
mifepristone, 06/08/2011 03/29/2016
IS
Myalept (metreleptin), injection, powder, lyophilized, for solution
BLA #125390
metreleptin, 02/24/2014 11/28/2016
IS
Mycophenolate
Shared System REMS
mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release, 09/25/2012 11/13/2015
Natpara (parathyroid hormone), injection, powder, lyophilized, for solution
BLA #125511
parathyroid hormone, 01/23/2015 08/04/2017
IS
Nplate (romiplostim), injection, powder, lyophilized, for solution
BLA #125268
romiplostim, 08/22/2008 12/06/2011
CP
Omontys (peginesatide), injection
NDA #202799
peginesatide, 03/27/2012 03/27/2012
CP
Opsumit (macitentan), tablet, film coated
NDA #204410
macitentan, 10/18/2013 08/25/2017
MG
IS
Pomalyst (pomalidomide), capsule
NDA #204026
pomalidomide, 02/08/2013 06/27/2017
IS
Probuphine (buprenorphine hydrochloride), implant
NDA #204442
buprenorphine hydrochloride, 05/26/2016 04/19/2017
MG
IS
Prolia (denosumab), injection
BLA #125320
denosumab, 06/01/2010 05/21/2015
MG
CP
Qsymia (phentermine and topiramate), capsule, extended release
NDA #022580
phentermine and topiramate, 07/17/2012 07/03/2017
MG
IS
Revlimid (lenalidomide), capsule
NDA #021880
lenalidomide, 08/03/2010 06/27/2017
IS
Saxenda (liraglutide), injection, solution
NDA #206321
liraglutide, 12/23/2014 05/22/2017
CP
Siliq (brodalumab), injection
BLA #761032
brodalumab, 02/15/2017 06/08/2017
IS
Sodium Oxybate
Shared System REMS
sodium oxybate, 01/17/2017 01/17/2017
MG
IS
Soliris (eculizumab), injection, solution, concentrate
BLA #125166
eculizumab, 06/04/2010 01/13/2017
MG
Suboxone/Subutex (buprenorphine and naloxone/buprenorphine), film, soluble; tablet
NDA #022410
NDA #020732
NDA #020733
buprenorphine and naloxone/buprenorphine,buprenorphine and naloxone/buprenorphine,buprenorphine and naloxone/buprenorphine, 08/30/2010 09/19/2017
MG
IS
Tanzeum (albiglutide), injection, powder, lyophilized, for solution
BLA #125431
albiglutide, 04/15/2014 07/27/2015
CP
Testim (testosterone), gel
NDA #021454
testosterone, 09/18/2009 05/11/2015
MG
testosterone (ANDA 076744) (testosterone), gel
ANDA #076744
testosterone, 09/25/2015 09/25/2015
MG
testosterone (ANDA 204255) (testosterone), solution
ANDA #204255
testosterone, 02/28/2017 02/28/2017
MG
testosterone (ANDA 204571) (testosterone), gel, metered
ANDA #204571
testosterone, 08/05/2015 08/05/2015
MG
testosterone (ANDA 205328) (testosterone), solution
ANDA #205328
testosterone, 08/07/2017 08/07/2017
MG
testosterone (NDA 202763) (testosterone), gel
NDA #202763
testosterone, 02/14/2012 07/01/2015
MG
testosterone (NDA 203098) (testosterone), gel
NDA #203098
testosterone, 01/31/2013 05/11/2015
MG
testosterone 1% (ANDA 076737) (testosterone), gel
ANDA #076737
testosterone, 11/05/2015 11/05/2015
MG
testosterone 1% (ANDA 091073) (testosterone), gel
ANDA #091073
testosterone, 09/18/2017 09/18/2017
MG
testosterone 1.62% (ANDA 204268) (testosterone), gel
ANDA #204268
testosterone, 08/04/2015 08/04/2015
MG
testosterone 1.62% (ANDA 205781) (testosterone), gel
ANDA #205781
testosterone, 07/12/2017 07/12/2017
MG
Thalomid (thalidomide), capsule
NDA #020785
thalidomide, 08/03/2010 06/27/2017
IS
Tracleer (bosentan), tablet, dispersible; tablet, film coated
NDA #021290
NDA #209279
bosentan,bosentan, 08/07/2009 09/05/2017
MG
IS
Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS
fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate, 12/28/2011 09/07/2017
MG
IS
Trulicity (dulaglutide), injection, solution
BLA #125469
dulaglutide, 09/18/2014 04/19/2017
CP
Tysabri (natalizumab), injection
BLA #125104
natalizumab, 10/07/2011 10/14/2016
MG
IS
Vigabatrin
Shared System REMS
vigabatrin,vigabatrin,vigabatrin, 04/27/2017 05/24/2017
IS
Vivitrol (naltrexone), kit
NDA #021897
naltrexone, 03/22/2010 05/17/2016
MG
CP
Vogelxo (testosterone), gel
NDA #204399
testosterone, 06/04/2014 08/11/2017
MG
Xiaflex (collagenase clostridium histolyticum), kit
BLA #125338
collagenase clostridium histolyticum, 02/02/2010 01/25/2017
IS
Xultophy (insulin degludec and liraglutide injection), injection
NDA #208583
insulin degludec and liraglutide injection, 11/21/2016 11/21/2016
CP
Xyrem (Sodium oxybate), solution
NDA #021196
Sodium oxybate, 02/27/2015 07/15/2015
MG
IS
Zinbryta (daclizumab), injection
BLA #761029
daclizumab, 05/27/2016 03/10/2017
CP
IS
Zydelig (idelalisib), tablet, film coated
NDA #205858
NDA #206545
idelalisib,idelalisib, 07/23/2014 01/04/2017
CP
Zyprexa Relprevv (olanzapine), kit
NDA #022173
olanzapine, 12/11/2009 10/30/2014
MG
CP
IS

*Many products within these REMS programs have Medication Guides not part of the REMS program. For a full list of Medication Guides click here.

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