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