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: downloadable data files.

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Name Last Updated Medication Guide* Communication Plan ETASU Implementation System Recall Type
Adasuve (loxapine), aerosol, powder
NDA #022549
10/19/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Adasuve, loxapine
Addyi (flibanserin), tablet
NDA #022526
05/10/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Addyi, flibanserin
Adempas (riociguat), tablet, film coated
NDA #204819
10/04/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Adempas, riociguat
Afrezza (insulin human), powder, metered
NDA #022472
04/01/2016  
 
    Communication Plan Afrezza, insulin human
Alosetron (alosetron), tablet
ANDA #200652
03/24/2016    
 
  Elements to Assure Safe Use, ETASU
Androgel 1% (testosterone), gel
NDA #021015
05/11/2015
 
      Medication Guide Androgel, testosterone
Androgel 1.62% (testosterone), gel
NDA #022309
05/11/2015
 
      Medication Guide Androgel 1.62%, testosterone
Aranesp (darbepoetin alfa), solution
BLA #103951
12/31/2013    
 
 
Implementation System Elements to Assure Safe Use, ETASU Aranesp, darbepoetin alfa
Aveed (testosterone undecanoate), injection
NDA #022219
03/05/2014    
 
 
Implementation System Elements to Assure Safe Use, ETASU testosterone undecanoate, testosterone undecanoate
Axiron (testosterone), solution
NDA #022504
05/11/2015
 
      Medication Guide Axiron, testosterone
Blincyto (blinatumomab), kit
BLA #125557
08/30/2016  
 
    Communication Plan Blincyto, blinatumomab
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS
10/04/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Bunavail, buprenorphine and naloxone, Zubsolv, buprenorphine and naloxone
Bupropion (ANDA 206122) (bupropion hydrochloride), tablet, extended release
ANDA #206122
08/17/2016
 
      Medication Guide
Caprelsa (vandetanib), tablet
NDA #022405
11/27/2013
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Communication Plan Medication Guide Caprelsa, vandetanib
Chantix (varenicline), kit
NDA #021928
08/12/2016
 
      Medication Guide Chantix, varenicline
Clozapine
Shared System REMS
09/15/2015    
 
 
Implementation System Elements to Assure Safe Use, ETASU Clozaril, clozapine, Fazaclo ODT, clozapine, Versacloz, clozapine
Entereg (alvimopan), capsule
NDA #021775
06/01/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Entereg, alvimopan
Epogen / Procrit (epoetin alfa), solution
BLA #103234
12/31/2013    
 
 
Implementation System Elements to Assure Safe Use, ETASU Epogen / Procrit, epoetin alfa
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
Shared System REMS
09/30/2016
 
 
 
  Elements to Assure Safe Use, ETASU Medication Guide Avinza, morphine sulfate, Belbuca, buprenorphine, Butrans, buprenorphine, Dolophine, methadone hydrochloride, Duragesic, fentanyl transdermal system, Embeda, morphine sulfate and naltrexone hydrochloride, Exalgo, hydromorphone hydrochloride, Hysingla ER, hydrocodone bitartrate, Kadian, morphine sulfate, Methadose, methadone hydrochloride, Morphabond, morphine sulfate, MS Contin, morphine sulfate, Nucynta ER, tapentadol, Opana ER, oxymorphone hydrochloride, OxyContin, oxycodone hydrochloride, Targiniq ER, oxycodone and naloxone hydrochloride, Troxyca ER, oxycodone hydrochloride and naloxone hydrochloride, Xtampza, oxycodone, Zohydro ER, hydrocodone
Extraneal (icodextrin), injection, solution
NDA #021321
10/24/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Extraneal, icodextrin
Farydak (panobinostat), capsule
NDA #205353
02/23/2015  
 
    Communication Plan Farydak, panobinostat
Forteo (teriparatide [rDNA origin]), injection, solution
NDA #021318
08/30/2013
 
 
    Communication Plan Medication Guide Forteo, teriparatide [rDNA origin]
Fortesta (testosterone), gel, metered
NDA #021463
05/11/2015
 
      Medication Guide Fortesta, testosterone
Gattex (teduglutide [rDNA origin]), injection, powder, for solution
NDA #203441
05/27/2016  
 
 
  Elements to Assure Safe Use, ETASU Communication Plan Gattex, teduglutide [rDNA origin]
Gilenya (fingolimod), capsule
NDA #022527
05/14/2015  
 
    Communication Plan Gilenya, fingolimod
Iclusig (ponatinib), tablet, film coated
NDA #203469
11/28/2016  
 
    Communication Plan Iclusig, ponatinib
Ionsys (fentanyl iontophoretic transdermal system), patch
NDA #021338
11/12/2015    
 
 
Implementation System Elements to Assure Safe Use, ETASU Ionsys, fentanyl iontophoretic transdermal system
Isotretinoin iPLEDGE
Shared System REMS
07/08/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Absorica, isotretinoin, Accutane, isotretinoin, Amnesteem, isotretinoin, Claravis, isotretinoin, Myorisan, isotretinoin, Sotret, isotretinoin, Zenatane, isotretinoin
Juxtapid (lomitapide), capsule
NDA #203858
08/13/2013    
 
 
Implementation System Elements to Assure Safe Use, ETASU Juxtapid, lomitapide
Kynamro (mipomersen sodium), injection, solution
NDA #203568
07/28/2015    
 
 
Implementation System Elements to Assure Safe Use, ETASU Kynamro, mipomersen sodium
Lemtrada (alemtuzumab), injection, solution, concentrate
BLA #103948
04/05/2016  
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Communication Plan Lemtrada, alemtuzumab
Letairis (ambrisentan), tablet, film coated
NDA #022081
10/02/2015
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Letairis, ambrisentan
Lotronex (alosetron hydrochloride), tablet
NDA #021107
04/29/2016    
 
  Elements to Assure Safe Use, ETASU Lotronex, alosetron hydrochloride
Mifeprex (mifepristone), tablet
NDA #020687
03/29/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Mifeprex, mifepristone
Myalept (metreleptin), injection, powder, lyophilized, for solution
BLA #125390
11/07/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Myalept, metreleptin
Mycophenolate
Shared System REMS
11/13/2015    
 
  Elements to Assure Safe Use, ETASU Cellcept, mycophenolate mofetil capsules, Cellcept, mycophenolate mofetil injection, Cellcept, mycophenolate mofetil oral suspension, Cellcept, mycophenolate mofetil tablets, Myfortic, mycophenolate acid delayed-release tablets
Natpara (parathyroid hormone), injection, powder, lyophilized, for solution
BLA #125511
09/29/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Natpara, parathyroid hormone
Nplate (romiplostim), injection, powder, lyophilized, for solution
BLA #125268
12/06/2011  
 
    Communication Plan Nplate, romiplostim
Nulojix (belatacept), injection, powder, lyophilized, for solution
BLA #125288
06/15/2011
 
 
    Communication Plan Medication Guide Nulojix, belatacept
Omontys (peginesatide), injection
NDA #202799
03/27/2012  
 
    Communication Plan Omontys, peginesatide
Opsumit (macitentan), tablet, film coated
NDA #204410
02/22/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Opsumit, macitentan
Pomalyst (pomalidomide), capsule
NDA #204026
04/22/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Pomalyst, pomalidomide
Probuphine (buprenorphine hydrochloride), implant
NDA #204442
06/14/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Probuphine, buprenorphine hydrochloride
Prolia (denosumab), injection
BLA #125320
05/21/2015
 
 
    Communication Plan Medication Guide Prolia, denosumab
Qsymia (phentermine and topiramate), capsule, extended release
NDA #022580
09/26/2014
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Qsymia, phentermine and topiramate
Revlimid (lenalidomide), capsule
NDA #021880
04/22/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Revlimid, lenalidomide
Sabril (vigabatrin), powder, for solution; tablet, film coated
NDA #020427
NDA #022006
06/27/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Sabril, vigabatrin
Saxenda (liraglutide), injection, solution
NDA #206321
02/01/2016  
 
    Communication Plan Saxenda, liraglutide
Soliris (eculizumab), injection, solution, concentrate
BLA #125166
07/12/2016
 
 
 
  Elements to Assure Safe Use, ETASU Medication Guide Soliris, eculizumab
Stelara (ustekinumab), injection, solution
BLA #125261
09/20/2013  
 
    Communication Plan Stelara, ustekinumab
Suboxone/Subutex (buprenorphine and naloxone/buprenorphine), film, soluble; tablet
NDA #020732
NDA #020733
NDA #022410
07/07/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Suboxone, buprenorphine and naloxone/buprenorphine, Subutex, buprenorphine and naloxone/buprenorphine
Symlin (pramlintide), injection
NDA #021332
09/18/2015  
 
    Communication Plan Symlin, pramlintide
Tanzeum (albiglutide), injection, powder, lyophilized, for solution
BLA #125431
07/27/2015  
 
    Communication Plan Tanzeum, albiglutide
Testim (testosterone), gel
NDA #021454
05/11/2015
 
      Medication Guide Testim, testosterone
testosterone (ANDA 076744) (testosterone), gel
ANDA #076744
09/25/2015
 
      Medication Guide
testosterone (ANDA 204571) (testosterone), gel, metered
ANDA #204571
08/05/2015
 
      Medication Guide
testosterone (NDA 202763) (testosterone), gel
NDA #202763
07/01/2015
 
      Medication Guide Testosterone Gel, testosterone
testosterone (NDA 203098) (testosterone), gel
NDA #203098
05/11/2015
 
      Medication Guide
testosterone 1% (ANDA 076737) (testosterone), gel
ANDA #076737
11/05/2015
 
      Medication Guide
testosterone 1.62% (ANDA 204268) (testosterone), gel
ANDA #204268
08/04/2015
 
      Medication Guide
Thalomid (thalidomide), capsule
NDA #020785
04/22/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Thalomid, thalidomide
Tracleer (bosentan), tablet, film coated
NDA #021290
12/04/2015
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Tracleer, bosentan
Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS
12/21/2015
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Abstral, fentanyl citrate, Actiq, fentanyl citrate, Fentora, fentanyl citrate, Lazanda, fentanyl citrate, Onsolis, fentanyl citrate, Subsys, fentanyl
Trulicity (dulaglutide), injection, solution
BLA #125469
07/27/2015  
 
    Communication Plan Trulicity, dulaglutide
Truvada (emtricitabine and tenofovir disoproxil fumarate), tablet, film coated
NDA #021752
03/10/2016    
 
  Elements to Assure Safe Use, ETASU Truvada, emtricitabine and tenofovir disoproxil fumarate
Tysabri (natalizumab), injection
BLA #125104
10/14/2016
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Tysabri, natalizumab
Vibativ (telavancin), injection, powder, lyophilized, for solution
NDA #022110
NDA #022407
03/23/2016
 
 
    Communication Plan Medication Guide Vibativ, telavancin
Victoza (liraglutide), injection, solution
NDA #022341
09/20/2016  
 
    Communication Plan Victoza, liraglutide
Vivitrol (naltrexone), kit
NDA #021897
05/17/2016
 
 
    Communication Plan Medication Guide Vivitrol, naltrexone
Vogelxo (testosterone), gel
NDA #204399
05/11/2015
 
      Medication Guide Vogelxo, testosterone
Xiaflex (collagenase clostridium histolyticum), kit
BLA #125338
11/28/2016    
 
 
Implementation System Elements to Assure Safe Use, ETASU Xiaflex, collagenase clostridium histolyticum
Xultophy (insulin degludec and liraglutide), injection
NDA #208583
11/21/2016  
 
    Communication Plan Xultophy, insulin degludec and liraglutide
Xyrem (Sodium oxybate), solution
NDA #021196
07/15/2015
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Medication Guide Xyrem, Sodium oxybate
Zinbryta (daclizumab), injection
BLA #761029
05/27/2016  
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Communication Plan Zinbryta, daclizumab
Zyban (bupropion hydrochloride), tablet, film coated
NDA #020711
03/27/2014
 
      Medication Guide Zyban, bupropion hydrochloride
Zydelig (idelalisib), tablet, film coated
NDA #205858
NDA #206545
07/23/2014  
 
    Communication Plan Zydelig, idelalisib
Zyprexa Relprevv (olanzapine), kit
NDA #022173
10/30/2014
 
 
 
 
Implementation System Elements to Assure Safe Use, ETASU Communication Plan Medication Guide Zyprexa Relprevv, olanzapine

*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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