Drugs

Approved Risk Evaluation and Mitigation Strategies (REMS)

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.  Additional REMS Information. 

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The three tables below provide separate lists for: 

Currently Approved Individual REMS

ProductApplication                      Date REMS Approved

REMS Components

(All REMS include timetable for assessment)

Actemra (tocilizumab) Injection (PDF - 1MB)                               BLA 125276/92; 1254721/8/2010;
modified 4/15/2011, 6/20/2012, 10/11/2012, 4/29/2013, 7/2/2013, 10/21/2013
communication                 plan                           
Adasuve (loxapine) Inhalation Powder (PDF - 6MB) NDA 22-549/S-00212/21/2012; modified 12/9/2013communication plan, elements to assure safe use, implementation system
Adempas (riociguat) Tablets (PDF - 6MB)  NDA 20481910/8/2013; 6/11/2014medication guide, elements to assure safe use, implementation system
Afrezza (insulin human) Inhalation Powder (PDF -350KB)NDA 0224726/27/2014communication plan
Androgel (testosterone) 1% Gel (PDF - 96KB) NDA 21-015/S-0369/18/2009; modified 3/10/2011, 11/30/2011, 5/20/2013,
6/19/2014 11/12/2014
medication guide
Androgel (testosterone) 1.62% Gel (PDF - 95KB) NDA 22-309/S-0084/29/2011; modified 9/7/2012, 5/20/2013; 6/19/2014 11/14/2014 medication guide
Aranesp (darbepoetin alfa) Injection (PDF - 28MB)BLA 103951/53232/16/2010; modified 6/24/2011, 5/31/2012, 12/31/2013elements to assure safe use,
implementation system
Aveed (testosterone undecanoate) (PDF - 3.60MB)NDA 022219/S-0003/5/2014elements to assure safe use,
implementation system
Axiron (testosterone) Topical Solution (PDF - 37KB) NDA 22-504/S-00211/23/2010; modified 3/31/2011; 6/19/2014medication guide
the word new in a red boxBlincyto (blinatumomab) (PDF - 432KB)BLA 12555712/4/2014communication plan
Bydureon (exenatide) Extended-Release for Injectable Suspension (PDF - 116KB)  NDA 22-2001/27/2012communication plan
Caprelsa (vandetanib) Tablets (PDF - 1MB) NDA 22-405/S-0054/6/2011; modified
6/22/2011, 11/27/2013
medication guide, communication plan, elements to assure safe use, implementation system
Chantix (varenicline) Tablets (PDF - 17KB) NDA 21-928/S-019, S-020, S-021,S-032,S-036, S-03810/19/2009; modified 4/22/2010, 7/22/2011 9/19/2014
10/15/2014 
medication guide
Eliquis (apixaban) Tablets (PDF - 280KB) NDA 202155

12/28/2012

8/19/2014

communication plan
Entereg (alvimopan) Capsules (PDF - 424KB) NDA 21-775/S-0105/20/2008
modified 2/5/2009, 9/25/2012, 10/18/2013
elements to assure safe use, implementation system
Epogen/Procrit (epoetin alfa) Injection (PDF - 28MB)BLA 103234/53232/16/2010; modified 6/24/2011, 5/31/2012, 12/31/2013elements to assure safe use, implementation system
Extraneal (icodextrin) Intraperitoneal Solution (PDF - 2743KB) NDA 21-321/S-020, S-021, S-0293/9/2011;
modified 2/25/2014
medication guide, elements to assure safe use, implementation system
Forteo (teriparatide [rDNA origin]) Injection (PDF - 116KB)  NDA 21-318/S-0277/22/2009; modified 3/13/2012; 8/30/2013medication guide, communication plan
Fortesta (testosterone) Gel (PDF - 50KB) NDA 21-463/S-010

12/29/2010; modified 9/11/2013 3/24/2014; 6/19/2014

7/31/2014

medication guide
Gattex (teduglutide [rDNA origin]) Injection (PDF - 1.3MB) NDA 20344112/21/2012, 6/26/2014communication plan, elements to assure safe use
Gilenya (fingolimod) Capsules (PDF - 473KB)  NDA 22-527/S-0109/21/2010; modifed 3/1/2012, 5/28/2013communication plan
Iclusig (ponatinib) Tablets (PDF - 1.4MB) NDA 203469/S-007, S-00812/20/2013communication plan
Juxtapid (lomitapide) Capsules (PDF - 5MB) NDA 203858/S-00112/21/2012; modified 8/13/2013elements to assure safe use, implementation system
Krystexxa (pegloticase) Injection (PDF - 854KB)  BLA 125293/609/14/2010; modified 10/19/2010, 4/16/2012. 10/10/2013communication plan
Kynamro (mipomersen sodium) (PDF - 12MB) NDA 2035681/29/2013, 5/7/2014
 
elements to assure safe use, implementation system
Lemtrada (alemtuzumab) (PDF - 8,638KB)BLA 10394811/14/2014communication plan, elements to assure safe use, implementation system
Letairis (ambrisentan) Tablets (PDF - 4MB) NDA 22-081/S-019; S-032

5/29/2009; modified 7/1/2009, 
8/5/2009, 8/24/2010, 10/13/2010, 3/3/2011, 2/15/2012, 10/19/2012, 8/17/2013

1/31/2014
10/29/2014
 

medication guide, elements to assure safe use, implementation system
Lotronex (alosetron hydrochloride) Tablets (PDF - 19.2MB)NDA 21-107/S-0149/2/2010, 5/8/2014medication guide, elements to assure safe use, implementation system
Mifeprex (mifepristone) Tablets (PDF - 205KB) NDA 20-687/S-0146/8/2011medication guide, elements to assure safe use, implementation system
Multaq (dronedarone) Tablets (PDF - 1.12MB)  NDA 22-425/S-016, S-017, S-0187/1/2009; modified 2/11/2011, 8/5/2011, 6/13/2012, 9/7/2012
3/19/2014
medication guide, communication plan
Myalept (metreleptin) Injection (PDF - 3MB) BLA 125390 S-0002/24/2014,
6/30/2014
elements to insure safe use, implementation system
Nplate (romiplostim) for Subcutaneous Injection (PDF - 45KB)  BLA 125268/778/22/2008; modified 8/14/2009, 3/23/2010, 7/29/2011, 12/6/2011communication plan
Nulojix (belatacept) (PDF -  946KB) BLA 1252886/15/2011medication guide, communication plan
Omontys (peginesatide) Injection (PDF - 165KB)  NDA 2027993/27/2012communication plan
Opsumit (macitentan) Tablets (PDF - 4MB) NDA 20441010/18/2013medication guide, elements to assure safe use, implementation system
Pomalyst (pomalidomide) Capsules (PDF - 8MB) NDA 204026/S-002,S-0042/8/2013; modified 11/15/2013 9/12/2014elements to assure safe use, implementation system
Potiga (ezogabine) Tablets (PDF - 524KB)  NDA 22-345/S-0016/10/2011; modified 3/19/2012communication plan
Prolia (denosumab) Injection (PDF - 41KB)  BLA 125320/1136/1/2010; modified 9/16/2011, 5/10/2012, 7/3/2013;
6/16/2014
medication guide, communication plan
Qsymia (phentermine and topiramate) Extended-Release Capsules (PDF - 5MB)  NDA 22-580/S-004, S-010,S-011,S-0127/17/2012; modified 11/1/2012, 4/16/2013
9/26/2014
medication guide, elements to assure safe use, implementation system
Revlimid (lenalidomide) Capsules (PDF - 8MB) NDA 21-880/S-035, S-039, S-040

8/3/2010; modified 5/9/2012, 2/8/2013, 6/5/2013, 11/15/2013 9/12/2014

 

elements to assure safe use, implementation system
Sabril (vigabatrin) Oral Solution (PDF - 1.9MB) NDA 22-006/S-011, S-012, S-0138/21/2009; modified 1/18/2011, 12/11/2012, 10/26/2013medication guide, communication plan, elements to assure safe use, implementation system
Sabril (vigabatrin) Tablets (PDF - 1.9MB) NDA 20-427/S-010, S-011, S-0128/21/2009; modified 1/18/2011, 12/11/2012, 10/26/2013medication guide, communication plan, elements to assure safe use, implementation system
Soliris (eculizumab) Injection (PDF - 1.17MB) BLA 125166/172

6/4/2010; modified 9/23/2011,
4/30/2014

10/10/2014

medication guide, elements to assure safe use
Stelara (ustekinumab) Injection (PDF - 314KB)
 
BLA 125261/1039/25/2009;  modified 12/30/2009, 10/20/2010, 5/2/2012, 9/20/2013communication plan
Suboxone (buprenorphine and naloxone) Sublingual Film (PDF - 3.65MB)NDA 22-4108/30/2010
Modified
4/28/2014
medication guide, elements to assure safe use, implementation system
Suboxone (buprenorphine and naloxone) Sublingual Tablets (PDF - 455KB)  NDA 20-733/S-007, S-00812/22/2011medication guide, elements to assure safe use, implementation system
Subutex (buprenorphine) Sublingual Tablets (PDF - 467KB) 
NDA 20-732/S-006, S-00712/22/2011medication guide, elements to assure safe use, implementation system
Symlin (pramlintide acetate) injection (PDF - 980KB)NDA 021-3326/27/2014communication plan
Tanzeum (Albiglutide) injection (PDF - 1.57MB)BLA 1254314/15/2014communication plan
Testim (testosterone) Gel (PDF - 32.36KB)  NDA 21-454/S-014

9/18/2009; modified 11/22/2011

5/1/2014; 6/19/2014

medication guide
Testosterone Gel (PDF - 13KB)  NDA 2027632/14/2012,
 6/19/2014
medication guide
Testosterone Gel (PDF - 13KB)  NDA 2030981/31/2013,
 6/19/2014
medication guide
Thalomid (thalidomide) Capsules (PDF - 8MB) NDA 20-785/S-050,S-0548/3/2010; modified 2/8/2013, 11/15/2013 9/12/2014elements to assure safe use, implementation system
Tikosyn (dofetilide) Capsules (PDF - 7.04MB)  NDA 20-931/S-007

7/11/2011;
modified

12/6/2013

medication guide, elements to assure safe use, implementation system
Tracleer (bosentan) Tablets (PDF - 3MB) NDA 21-290/S-0258/7/2009; modified 2/19/2010, 10/2/2012, 7/1/2013medication guide, elements to assure safe use, implementation system
Trulicity (Dulaglutide) (PDF - 223KB)BLA 125469S-0009/18/2014communication plan
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets (PDF - 9MB)  NDA 21-752/S-0357/16/2012; modified 6/17/2013; 6/18/2014medication guide, elements to assure safe use
Tysabri (natalizumab) Intravenous Injection (PDF - 13MB)  BLA 125104/840, 847, 88910/7/2011; modified 1/20/2012, 5/24/2013, 12/15/2013medication guide, elements to assure safe use, implementation system
Versacloz (clozapine) Oral Suspension (PDF - 1.09MB)  NDA 203479-001

2/6/2013;
modified

12/6/2013

elements to assure safe use, implementation system
Vibativ (telavancin) Injection (PDF - 94KB)  NDA 22-110/S-003; 22-4079/11/2009; modified 7/27/2011, 6/21/2013 11/12/2014medication guide, communication plan
Victoza (liraglutide) Injection (PDF - 1025KB) NDA 22-341/S-004

1/25/2010; modified 5/18/2011

7/31/2014
 

communication plan
Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF - 756KB) NDA 21-897/S-020, S-0233/22/2010; modified 10/12/2010, 7/29/2013medication guide, communication plan
 
Vogelxo (testosterone) gel (PDF - 32KB)NDA 2043996/19/2014medication guide 
Xeljanz (tofacitinib) Tablets (PDF - 381KB) NDA 203214/S-00611/6/2012; modified 11/8/2013
3/26/2014
medication guide, communication plan
Xenazine (tetrabenazine) Tablets (PDF - 2MB) NDA 21-894/S-0098/15/2008; modified 12/1/2009, 5/4/2011, 8/17/2012, 8/2/2013communication plan
Xiaflex (collagenase clostridium histolyticum) Injection (PDF - 6.15MB)  BLA 125338/S-06; S-084

2/2/2010; modifed 2/24/2012

12/6/2013

10/20/2014

communication plan, elements to assure safe use, implementation system

Yervoy (ipilimumab) Injection (PDF - 3MB)  BLA 125377/163/25/2011; modified 2/16/2012communication plan
Zyban (bupropion hydrochloride) Sustained-Release Tablets (PDF - 19KB)NDA 20-711/S-034

2/26/2010

modified 3/27/2014

medication guide
Zydelig (idelalisib) tablets NDA 20-5858; 206545

7/23/2014

communication plan
Zyprexa Relprevv (olanzapine) Extended-Release Injection (PDF - 3MB) NDA 22-173/S-01812/11/2009; modified 7/8/2010, 8/3/2012, 3/27/2013medication guide, communication plan, elements to assure safe use, implementation system

Currently Approved Shared System REMS   

Name of Shared System REMS (and included products)Date REMS ApprovedREMS Components (All REMS include timetable for assessment)
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS (PDF - 5MB)  2/22/2013;
modifed
9/4/2013
 
medication guide,
elements to assure safe use,
implementation system 

UpdatedExtended-Release and Long-Acting Opioid Analgesics REMS (PDF - 2394KB) 

7/9/2012; modified 8/28/2012, 4/15/2013 6/30/2014, 11/20/2014*

7/23/2014
8/19/2014
 

medication guide,
elements to assure safe use

 

Isotretinoin iPLEDGE REMS (PDF - 9MB) 

10/22/2010; modified 4/12/2012    medication guide,
elements to assure safe use,
implementation system

Mycophenolate REMS (PDF - 2.06MB) 

9/25/2012;
modified
9/27/2013

 

medication guide,
elements to assure safe use

Rosiglitazone REMS (PDF - 4.1MB) 

9/16/2013; 5/7/2014
elements to assure safe use,

Transmucosal Immediate-Release Fentanyl (TIRF) Products (PDF - 2MB)  

  • List of application numbers and sponsors (PDF - 16KB) (updated 9/10/2014)  
    • Abstral (fentanyl) Sublingual Tablets
    • Actiq (fentanyl citrate) Oral Transmucosal Lozenge and the generic equivalents
    • Fentora (fentanyl citrate) Buccal Tablets
    • Lazanda (fentanyl) Nasal Spray 
    • Onsolis (fentanyl) Buccal Soluble Film
    • Subsys (fentanyl) Sublingual Spray
    • Generic Transmucosal Immediate Release Fentanyl (TIRF) Products

12/28/2011;
modified
6/5/2012,
11/7/2013

 

medication guide,
elements to assure safe use,
implementation system  
 

 

*The chart above reflects the most up-to-date version of each Shared System REMS.  For the shared system with the asterisk, the process of making corresponding changes to all REMS in the shared system is underway.

Page Last Updated: 12/05/2014
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