Approved Risk Evaluation and Mitigation Strategies (REMS)


Name Application Date REMS Approved REMS Components  (All REMS include timetable for assessment) 
Abstral (fentanyl) Sublingual Tablets (PDF – 4702KB)1  NDA 22-510 1/7/2011          medication guide, elements to assure safe use, implementation system                       
Actemra (tocilizumab) Injection (PDF – 1186KB)2   BLA 125276/22 1/8/2011; modified 4/15/2011 communication plan
Actiq (fentanyl citrate) Oral Transmucosal Lozenge (PDF – 2MB)3  NDA 20-747/S-029 7/20/2011 medication guide, elements to assure safe use, implementation system
Actonel (risedronate sodium) Tablets   NDA 20-835/S-044 1/25/2011; released from REMS requirement 8/22/2011  
Actonel with Calcium (risedronate sodium and calcium carbonate) Tablets   NDA 21-823/S-008 1/25/2011; released from REMS requirement 8/22/2011  
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets (PDF – 207KB)4  NDA 21-842/S-014, S-015 9/14/2009; modified 10/21/2009, 8/4/2011 medication guide
Actoplus Met XR (pioglitazone and metformin) Extended-Release Tablets (PDF – 195KB)5  NDA 22-024/S-007, S-008 5/12/2009; modified 12/22/2010, 8/4/2011 medication guide
Actos (pioglitazone hydrochloride) Tablets (PDF – 160KB)6  NDA 21-073/S-043, S-044 9/9/2009; modified 2/3/2011, 8/4/2011 medication guide
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) (PDF – 284KB)7   NDA 21-077/S-047 4/30/2008; modified 1/4/2011, 5/10/2011, 6/27/2011 communication plan
Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) (PDF – 277KB)8   NDA 21-254/S-016 7/31/2008; modified 9/15/2009, 1/4/2011, 5/10/2011, 6/27/2011 communication plan
Ampyra (dalfampridine) Extended-Release Tablets (PDF – 60KB)9 NDA 22-250 1/22/2010 medication guide, communication plan
Androgel (testosterone) Gel (PDF – 90KB)10  NDA 21-015/S-028 9/18/2009; modified 3/10/2011 medication guide
Androgel (testosterone) 1.62% Gel (PDF – 98KB)11 NDA 22-309 4/29/2011 medication guide
Aplenzin (buproprion hydrobromide) Extended-Release Tablets   NDA 22-108/S-002 4/23/2008; released from REMS requirement  
4/29/2011
Aranesp (darbepoetin alfa) Injection (PDF – 16MB)12  BLA 103951/5173, 5258 2/16/2010; modified 6/24/2011 medication guide, communication plan, elements to assure safe use, implementation system
Arcapta Neohaler (indacaterol maleate) Inhalation Powder (PDF – 154KB)13   NDA 22-383 7/1/2011 communication plan
Atelvia (risedronate sodium) Delayed-Release Tablets    NDA 22-560/S-003 1/25/2011; released from REMS requirement 8/22/2011  
Avandamet (rosiglitazone maleate and metformin NDA 21-410/S-027 12/2/2008; modified 5/18/2011 medication guide, communication plan, elements to assure safe use, implementation system
hydrochloride) Tablets (PDF – 3MB)14 
Avandaryl (rosiglitazone maleate and glimepiride) Tablets (PDF – 3MB)15  NDA 21-700/S-011 12/2/2008; modified 5/18/2011 medication guide, communication plan, elements to assure safe use, implementation system
Avandia (rosiglitazone maleate) Tablets (PDF – 3MB)16  NDA 21-071/S-039 5/18/2011 medication guide, communication plan, elements to assure safe use, implementation system
Avelox (moxifloxacin) Tablets and I.V. Solution   NDA 21-085/S-052; 21-277/S-049 4/27/2009; released from REMS requirement 8/3/2011  
Axiron (testosterone) Topical Solution (PDF – 37KB)17  NDA 22-504/S-002 11/23/2010; modified 3/31/2011 medication guide
Banzel (rufinamide) Tablets and Oral Suspension   NDA 21-911/S-008; 201367/S-001 11/14/2008; modified 11/8/2010, 3/3/2011;  
released from REMS requirement 6/10/2011
Boniva (ibandronate sodium) Injection   NDA 21-858/S-012 1/25/2011; released from REMS requirement  
7/1/2011
Boniva (ibandronate sodium) Tablets NDA 21-455/S-013 1/25/2011; released from REMS requirement  
7/1/2011
Botox/Botox Cosmetic (onabotulinumtoxinA) Injection (PDF – 198KB)18  BLA 103000/5232 7/31/2009; modified 3/9/2010, 10/15/2010, 8/24/2011 medication guide, communication plan
Brilinta (ticagrelor) Tablets (PDF – 248KB)19  NDA 22-433 7/20/2011 medication guide, communication plan
Brovana (arformoterol tartrate) Inhalation Solution (PDF – 217KB)20 NDA 21-912/S-015 6/2/2010; modified 2/1/2011, 2/16/2011 medication guide, communication plan
Butrans (buprenorphine) Transdermal System (PDF – 382KB)21 NDA 21-306/S-001 6/30/2010 medication guide, elements to assure safe use
Byetta (exanatide) Injection   NDA 21-773/S-031 10/30/2009; released from REMS requirement 8/5/2011  
Cambia (diclofenac potassium) Oral Solution   NDA 22-165/S-004 6/17/2009; released from REMS requirement  
7/20/2011
Caprelsa (vandetanib) Tablets (PDF – 6MB)22 (see vandetanib)  NDA 22-405/S-001 4/6/2011; modified medication guide, communication plan, elements to assure safe use, implementation system
6/22/2011
Carbatrol (carbamazepine) Extended-Release Capsules    NDA 20-712/S-034 1/26/2011; released from REMS requirement 8/22/2011  
Celontin (methsuximide) Capsules   NDA 10-592/S-023 10/11/2010;  
released from REMS requirement 6/15/2011
Chantix (varenicline) Tablets (PDF – 17KB)23  NDA 21-928/S-019, S-020, S-21 10/19/2009; modified 4/22/2010, 7/22/2011 medication guide
Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection Updated! BLA 125160/155 modified 12/31/2008, 5/13/2009, 11/3/2009; released from REMS requirement 7/26/2011  
Cipro (ciprofloxacin) Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets  NDA 19-537/S-079; 19-847/S-051; 19-857/S-058; 20-780/S-037; 21-473/S-032 4/27/2009; released from REMS requirement 8/3/2011  
Colcrys (colchicine) Tablets  Updated! NDA 22-351 7/30/2009; released from REMS requirement  
7/20/2011
Colcrys (colchicine) Tablets   NDA 22-352/S-013, S-014 7/29/2009; modified 4/29/2010; released from REMS requirement  
7/20/2011
Colcrys (colchicine) Tablets Updated! NDA 22-353 10/16/2009; released from REMS requirement  
7/20/2011
Copegus (ribavirin) Tablets    NDA 21-511/S-024 6/9/2010; modified 10/8/2010; released from REMS requirement 5/9/2011  
Creon (pancrelipase) Delayed-Release Capsules   NDA 20-725/S-014 4/30/2009; modified 8/12/2010; released from REMS requirement 5/9/2011  
Darvon Capsules, Darvon-N Tablets, and Darvocet-N (propoxyphene) Tablets (PDF – 22KB)24 NDA 10-997/S-051, S-052; 16-062/S-041, S-042; 17-122/S-061, S-062 9/25/2009 medication guide
Dilantin (phenytoin) Oral Suspension   NDA 8762/S-042 1/17/2011; released from REMS requirement 5/27/2011  
Duetact (pioglitazone hydrochloride and glimepiride) Tablets (PDF – 170KB)25  NDA 21-925/S-010, S-011 9/9/2009; modified 8/4/2011 medication guide
Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol (PDF – 251KB)26   NDA 22-518/S-002, S-004 6/22/2010; modified 8/18/2011 communication plan
Dysport (abobotulinumtoxinA) Injection (PDF – 1020KB)27 BLA 125274/0, 125274/1 4/29/2009 medication guide, communication plan
Edluar (zolpidem tartrate) NDA 21-997/S-003 3/13/2009; modified 12/17/2010; released from REMS requirement  8/10/2011  
Sublingual Tablets  
Effient (prasugrel) Tablets (PDF – 990KB)28   NDA 22-307/S-003 7/10/2009; modified medication guide, communication plan
4/16/2010, 12/6/2010, 9/26/2011
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules (PDF – 47KB)29 NDA 22-321 8/13/2009 medication guide, communication plan
Enbrel (etanercept) for Subcutaneous Injection   BLA 103795/5474 6/23/2008; modified 6/3/2010, 7/20/2010, 10/13/2010; released from REMS requirement 8/10/11  
Entereg (alvimopan) Capsules (PDF – 2120KB)30 NDA 21-775 modified 2/5/2009 communication plan, elements to assure safe use, implementation system
Epogen/Procrit (epoetin alfa) Injection (PDF – 16MB)31  BLA 103234/5166, 5266 2/16/2010; modified 6/24/2011 medication guide, communication plan, elements to assure safe use, implementation system
Epzicom (abacavir sulfate and lamivudine) Tablets   NDA 21-652/S-013 3/9/2009; modified 8/4/2010, 2/2/2011; released from REMS requirement 5/13/2011  
Equetro (carbamazepine) Extended-Release Capsules (PDF – 32KB)32 NDA 21-710/S-008 10/24/2010 medication guide
Exalgo (hydromorphone hydrochloride) Extended-Release Tablets (PDF – 1660KB)33 NDA 21-217 3/1/2010; modified 3/24/2010 medication guide, elements to assure safe use
Extavia (interferon beta-1b)   BLA 125290/30 8/14/2009; released from REMS requirement  
6/22/2011
Extraneal (icodextrin) Intraperitoneal Solution (PDF – 2411KB)34  NDA 21-321/S-020, S-021 3/8/2011 medication guide, elements to assure safe use, implementation system
Factive (gemifloxacin) Tablets  NDA 21-158/S-015 4/27/2009; released from REMS requirement 8/4/2011  
Fentora (fentanyl citrate) Buccal Tablet (PDF – 2MB)35  NDA 21-947/S-009 7/20/2011 medication guide, elements to assure safe use, implementation system
Foradil (formoterol fumarate) Inhalation Powder (PDF – 306KB)36  NDA 20-831/S-022 5/18/2011 communication plan
Forteo (teriparatide [rDNA origin]) Injection (PDF – 115KB)37 NDA 21-318/S-012 7/22/2009 medication guide, communication plan
Fortesta (testosterone) Gel (PDF – 30KB)38 NDA 21-463 12/29/2010 medication guide
Fosamax (alendronate sodium) Oral Solution and Tablets   NDA 20-560/S-061; NDA 21-575/S-021 1/25/2011; released from REMS requirement 7/1/2011  
Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets   NDA 21-762/S-015 1/25/2011; released from REMS requirement 7/1/2011  
Gabitril (tiagabine hydrochloride) Tablets (PDF – 28KB)39  NDA 20-646/S-017 10/11/2010 medication guide
Gilenya (fingolimod) Capsules (PDF – 439KB)40 NDA 22-527 9/21/2010 medication guide, communication plan
Gralise (gabapentin) Tablets   NDA 22-544/S-003 1/28/2011; released from REMS requirement  
4/28/2011
HalfLytely Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride)  NDA 21-551/S-016 7/16/2010; released from REMS requirement  
7/6/2011
H.P. Acthar Gel (repository corticotropin) Injection (PDF – 56KB)41 NDA 22-432 10/15/2010 medication guide
Humira (adalimumab) Injection (PDF – 39KB)42 Updated! BLA 125057/254 4/8/2010; modified 3/14/2011, 7/13 2011 communication plan
Infergen (interferon alfacon-1)   BLA 103663/5088 8/7/2009; modified 7/2/2010;  
released from REMS requirement 6/1/2011
Intron A (interferon alfa-2b)   BLA 103132/5153 5/2/2008; modified 8/7/2009, 2/1/2011; released from REMS requirement 5/13/2011  
Invirase (saquinavir mesylate) Capsules and Tablets   NDA 20-628/S-037; 21-785/S-014 10/6/2010;  
released from REMS requirement 5/26/2011
Isotretinoin Capsules (PDF – 315KB)43  List of application numbers and sponsors (PDF – 21KB)44 10/22/2010 medication guide, elements to assure safe use, implementation system
Janumet (sitagliptin/metformin) Tablets  NDA 22-044/S-016 2/26/2010; released from REMS requirement 4/14/2011  
Januvia (sitagliptin) Tablets  NDA 21-995/S-017 2/26/2010; released from REMS requirement 4/14/2011  
Kalbitor (ecallentide) Injection (PDF – 155KB)45   BLA 125277/37 12/1/2009; modified 4/5/2011, 8/17/2011 communication plan
Kaletra (lopinavir and ritonavir) Tablets and Oral Solution   NDA 21-906/S-033; 21-251/S-040 4/6/2009; modified 1/29/2010, 4/27/2010, 6/14/2010, 2/24/2011; released from REMS requirement 5/6/2011  
Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection    NDA 21-035/S-090; 21-505/S-029; 22-285/S-014 4/23/2009; released from REMS requirement 8/10/2011  
Ketek (telithromycin) Tablets (PDF – 30KB)   NDA 21-144/S-015 12/8/2010; released from REMS requirement 6/20/2011  
Klonopin (clonazepam) Tablets and Orally Disintegrating Tablets (PDF – 46KB)46 NDA 17-533/S- 046, S-048;  20-813/S-006, S-007 9/1/2010 medication guide
Krystexxa (pegloticase) Injection (PDF – 889KB)47  BLA 125293/001 9/14/2010; modified 10/19/2010 medication guide, communication plan
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets (ODT)   NDA 20-241/S-048; 20-764/S-041; 22-251/S-011 4/23/2009, 5/8/2009, 5/29/2009, 10/24/2010; released from REMS requirement 5/31/2011  
Lamictal XR (lamotrigine) Extended-Release Tablets NDA 22-115/S-006 5/29/2009; modified 1/29/2010, 4/14/2010,  10/24/2010; released from REMS requirement 4/25/2011  
Lariam (mefloquine hydrochloride) Tablets   NDA 19-591/S-030 8/20/2009; released from REMS requirement 4/29/2011  
Lazanda (fentanyl) Nasal Spray (PDF – 1MB)48  NDA 22-569 6/30/2011 medication guide, elements to assure safe use, implementation system
Letairis (ambrisentan) Tablets (PDF – 3562KB)49  NDA 22-081/S-017 5/29/2009; modified 7/1/2009,  medication guide, elements to assure safe use, implementation system
8/5/2009, 8/24/2010, 10/13/2010, 3/3/2011
Levaquin (levofloxacin) Tablets, Injection, and Oral Solution (PDF – 34KB)50  NDA 20-634/ S-053; 20-635/ S-058; 21-721/ S-021 4/27/2009 medication guide
Lotronex (alosetron hydrochloride) Tablets (PDF – 18MB)51 NDA 21-107/S-014 9/2/2010 medication guide, elements to assure safe use, implementation system
Lumizyme (alglucosidase alfa) (PDF – 3MB)52  BLA 125291/43 5/24/2010; modified 9/12/2011 communication plan, elements to assure safe use, implementation system
Lyrica (pregabalin) Capsules and Oral Solution  NDA 22-488/S-001, S-002, S-003; 21-446/S-023, S-024 2/23/2009; modified 1/4/2010; released from REMS requirement 4/26/2011  
Meridia (subutramine hydrochloride) Capsules (PDF – 250KB)53 NDA 20-632/S-034, S-035 8/4/2010 medication guide
Metoclopramide Oral Solution (PDF – 24KB)54 ANDA 73-680/S-018 9/11/2009 medication guide
Metoclopramide Oral Solution (PDF – 31KB)55 ANDA 74-703/S-007 9/15/2009 medication guide
Metoclopramide Oral Solution (PDF – 24KB)56 ANDA 72-744/S-011 9/15/2009 medication guide
Metoclopramide Oral Solution (PDF – 24KB)57 ANDA 71-402/S-008 9/16/2009 medication guide
Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets   NDA 22-246/S-005 9/4/2009; released from REMS requirement 8/22/2011  
Mifeprex (mifepristone) Tablets (PDF – 205KB)58  NDA 20-687/S-014 6/8/2011 medication guide, elements to assure safe use, implementation system
Morphine Sulfate Oral Solution Updated! NDA 22-195/S-005 1/25/2010; released from REMS requirement 10/18/2011  
Multaq (dronedarone) Tablets (PDF – 1MB)59   NDA 22-425/S-006 7/1/2009; modified 2/11/2011, 8/5/2011 medication guide, communication plan
Myobloc (rimabotulinumtoxinB) Injection (PDF – 361KB)60 BLA 103846/5120 7/31/2009 medication guide, communication plan
Mysoline (primidone) Tablets    NDA 9170/S-038 7/21/2010; released from REMS requirement 8/10/2011  
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution   NDA 20-235/S-050; 20-882/S-035; 21-129/S-033 10/11/2010; released from REMS requirement 8/10/2011  
Noroxin (norfloxacin) Tablets  NDA 19-384/S-058 4/27/2009; released from REMS requirement 9/8/2011  
Nplate (romiplostim) for Subcutaneous Injection (PDF – 2MB)61 Updated! BLA 125268/80 8/22/2008; modified 8/14/2009, 3/23/2010, 7/29/2011 medication guide, communication plan,
elements to assure safe use, implementation system
Nucynta ER (tapentadol) Extended-Release Tablets (PDF – 1MB)62   NDA 200533 8/25/2011        medication guide, elements to assure safe use
Nulojix (belatacept) (PDF -  946KB)63  BLA 125288 6/15/2011 medication guide, communication plan
Nuvigil (armodafinil) Tablets (PDF 717KB)64 NDA 21-875/S-005, S-008, S-015 10/21/2010 medication guide, communication plan
Oleptro (trazadone hydrochloride) Extended-Release Tablets   NDA 22-411/S-005, S-006 2/2/2010; released from REMS requirement 5/11/2011  
Onsolis (fentanyl buccal soluble film) (PDF – 6039KB)65  NDA 22-266/S-001 7/16/2009; modified 7/1/2010 medication guide, communication plan, elements to assure safe use, implementation system
Osmoprep (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets (PDF – 28KB)66 NDA 21-892/S-004 10/13/2009 medication guide, communication plan
Oxycodone Hydrochloride Oral Solution (PDF – 26KB)67 NDA 200535 10/20/2010 medication guide
Oxycontin (oxycodone hydrochloride) Controlled-Release Tablets (PDF – 596KB)68  NDA 22-272/S-006 4/5/2010; modified 6/29/2010, 11/15/2010 medication guide, elements to assure safe use
Pancreaze (pancrelipase) Delayed-Release Capsules    NDA 22-523/S-002 4/12/2010; released from REMS requirement 6/20/2011  
Peganone (ethotoin) Tablets  NDA 10-841/S-023 6/7/2010; released from REMS requirement 5/31/2011  
Pegasys (peginterferon alfa-2a)  BLA 103964/5216 10/31/2008;  modified 8/7/2009, 5/24/2010, 2/23/2011; released from REMS  requirement 5/9/2011  
PegIntron (peginterferon alfa-2b)   BLA 103949/5211 12/11/2008; modified 8/7/2009, 2/1/2011; released from REMS requirement 5/13/2011  
PegIntron Rebetol Combopack (Peginterferon alfa-2b, Redipen Single-dose Delivery System and Rebetol Ribavirin) (PDF – 512KB)69 BLA 125196/0 6/13/2008 medication guide
Pennsaid (diclofenac sodium) Topical Solution   NDA 20-947/S-007 11/4/2009; modified 3/25/2010; released from REMS requirement  
7/14/2011
Perforomist (formoterol fumarate) Inhalation Solution (PDF – 621KB)70  NDA 22-007/S-005 2/1/2011 medication guide, communication plan
Plavix (clopidogrel bisulfate) Tablets   NDA 20-839/S-053 2/1/2011; released from REMS requirement 5/3/2011  
Potiga (ezogabine) Tablets (PDF – 524KB) 71 NDA 22-345 6/10/2011 communication plan
Pradaxa (dabigatran etexilate mesylate) Capsules   NDA 22-512/S-005 10/19/2010; released from REMS requirement 4/5/2011  
Prolia (denosumab) Injection (PDF – 99KB)72   BLA 125320/5, 6 6/1/2010; modified 9/16/2011 medication guide, communication plan
Promacta (eltrombopag) Tablets (PDF – 9624KB)73  NDA 22-291/S-001 11/20/2008; modified 3/5/2010, 2/25/2011 medication guide, elements to assure safe use, implementation system
Propylthiouracil (propylthiouracil) Tablets   NDA 06-188/S-021, S-022 4/1/2010; released from REMS requirement  
7/27/2011
Proquin XR (ciprofloxacin) Extended-Release Tablets   Updated! NDA 21-744/S-019 4/27/2009; released from REMS requirement 8/15/2011  
Provigil (modafinil) Tablets (PDF – 717KB)74 NDA 20-717/S-030, S-034, S-036 10/21/2010 medication guide, communication plan
Qualaquin (quinine sulfate) Capsules (PDF – 161KB)75 NDA 21-799/S-011 6/15/2010 medication guide, communication plan
Rapamune (sirolimus) Oral Solution and Tablets   NDA 21-083/S-050; NDA 21-110/S-060 11/23/2010; released from REMS requirement 6/6/2011  
Rebetol (ribivarin) Capsules and Oral Solution   NDA 20-903/S-048; 21-546/S-004 11/6/2009; modified 10/28/2010;  
released from REMS requirement 4/19/2011
Reclast (zoledronic acid) Injection   NDA 21-817/S-013 1/25/2011; released from REMS requirement 8/15/2011  
Reglan ODT (metoclorpramide hydrochloride) Orally Disintegrating Tablets   NDA 21-793/S-009 9/4/2009; released from REMS requirement 8/2/2011  
Reglan (metoclopramide hydrochloride) Tablets   NDA 17-854/S-056 9/4/2009; released from REMS requirement 8/2/2011  
Remicade (infliximab) Vial   BLA 103772/5317 11/18/2009; modified 2/17/2011; released from REMS requirement 8/1/2011  
Revlimid (lenalidomide) Capsules (PDF – 3819KB)76  NDA 21-880/S-013 8/3/2010 medication guide, elements to assure safe use, implementation system
Roferon-A Interferon (alfa-2a, recombinant) Injection   BLA 103145/5098 8/28/2009; released from REMS requirement  
6/16/2011
Rozerem (ramelteon) Tablets    NDA 21-782/S-015 10/20/2008; released from REMS requirement 8/4/2011  
Sabril (vigabatrin) Tablets and Oral Solution (PDF – 1533KB)77 NDA 22-006/S-002; 20-427/S-002 8/21/2009; modified 1/18/2011 medication guide, communication plan, elements to assure safe use, implementation system
Samsca (tolvaptan) Tablets (PDF – 781KB)78   NDA 22-275/S-003 5/19/2009; modified 9/23/2011 communication plan
Savella (milnacipran hydrochloride) NDA 22-256/S-010 1/14/2009; modified 2/2/2010; released from REMS requirement 4/26/2011  
Tablets  
 
Serevent Diskus (salmeterol xinafoate) Inhalation Powder (PDF – 276KB)79   NDA 20-692/S-039 11/18/2010; modified 5/10/2011, 6/27/2011 communication plan
Seroquel (quetiapine) Tablets (PDF – 19KB)80  NDA 20-639/S-045, S-046 12/2/2009 medication guide
Seroquel XR (quetiapine) Extended-Release Tablets (PDF – 19KB)81 NDA 22-047/S-011, S-016, S-017, S-019, S-022 12/2/2009 medication guide
Silenor (doxepin) Tablets (PDF – 60KB)82 NDA 22-036 3/17/2010 medication guide
Simponi (golimumab) Injection  BLA 125289/20 4/24/2009; modified 11/3/2009, 7/29/2010; released from REMS requirement 3/17/2011  
Soliris (eculizumab) Injection (PDF – 122KB)83  BLA 125166/44 6/4/2010 medication guide, elements to assure safe use
Stelara (ustekinumab) Injection (PDF – 1691KB)84  BLA 125261/13 9/25/2009;  modified 12/30/2009, 10/20/2010 medication guide, communication plan
Suboxone (buprenorphine and naloxone) Sublingual Film (PDF – 960KB)85 NDA 22-410 8/30/2010 medication guide, elements to assure safe use, implementation system
Sucraid (sacrosidase) Oral Solution  NDA 20-772/S-011 11/20/2008; released from REMS requirement 12/9/2010  
Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution   NDA 22-372/S-003 8/5/2010;  
released from REMS requirement
7/6/2011
Sutent (sunitinib) Capsules   NDA 21-938/S-013, S-017, S-018 7/1/2010; released from REMS requirement 5/19/2011  
Symbicort (budesonide and formoterol) Inhalation Aerosol (PDF – 1MB)86   NDA 21-929/S-028 2/27/2009; modified 2/16/2011, 8/18/2011 communication plan
Symbyax (olanzapine and fluoxetine) Capsules   NDA 21-520/S-031, S-032 3/19/2009; released from REMS requirement 6/21/2011  
Tapentadol Tablets (PDF – 222KB)87 NDA 22-304 11/20/2008 medication guide
Tasigna (nilotinib) Capsules (PDF – 9399KB)88  NDA 22-068/S-006 3/15/2010; modified 6/17/2010, 1/14/2011 medication guide, communication plan
Tegretol and Tegretol-XR (carbemazepine) Tablets, ChewableTablets, Suspension, and Extended-Release Tablets (PDF- 41KB)89  NDA 16-608/S-100, S-102; 18-281/S-049, S-050; 18-927/S-041, S-042; 20-234/S-031, S-033 3/3/2011 medication guide
Testim (testosterone) Gel (PDF – 22KB)90 NDA 21-454/S-008 9/18/2009 medication guide
Thalomid (thalidomide) Capsules (PDF – 5402KB)91 NDA 20-785/S-039 8/3/2010 medication guide, elements to assure safe use, implementation system
Tikosyn (dofetilide) Capsules (PDF – 2MB)92   NDA 20-931/S-003 7/11/2011 medication guide, elements to assure safe use, implementation system
Topamax (topiramate) Tablets and Sprinkle Capsules   NDA 20-505/S-046; 20-844/S-038 4/23/2009; modified 3/4/2011; released from REMS requirement  
6/27/2011
Tracleer (bosentan) Tablets (PDF – 1000KB)93 NDA 21-290/S-018 8/7/2009; modified 2/19/2010 medication guide, elements to assure safe use, implementation system
Tranxene (clorazepate dipotassium) Tablets   NDA 17-105/S-077 6/7/2010; released from REMS requirement  
7/19/2011
Treximet (sumatriptan succinate and naproxen sodium) Tablets   NDA 21-926/S-006 4/15/2008; released from REMS requirement 9/23/2011  
Trileptal (oxcarbazepine) Tablets and Suspension (PDF – 39KB)94  NDA 21-014/S-015, S-019, S-022, S-024, S-025, S-027, S-028; 21-285/S-009, S-013, S-015, S-018, S-019, S-020, S-022 3/3/2011 medication guide
Trilipix (fenofibric acid) Delayed-Release Capsules   NDA 22-224/S-005, S-006 12/15/2008; modified 9/14/2010; released from REMS requirement 9/30/2011  
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets   NDA 21-205/S-028 3/9/2009; modified 8/4/2010, 3/31/2011; released from REMS requirement 5/13/2011  
Tyzeka (telbivudine) Oral Solution  NDA 22-154/S-008 4/28/2009; modified 9/10/2010; released from REMS requirement 5/5/2011  
Tyzeka (telbivudine) Tablets   NDA 22-011/S-011 1/23/2009; modified 9/10/2010; released from REMS requirement 5/5/2011  
Vandetanib (vandetanib) Tablets (PDF – 6MB)95 (see Caprelsa)  NDA 22-405/S-001 4/6/2011; modified 6/22/2011 medication guide, communication plan, elements to assure safe use, implementation system
Venlafaxine hydrochloride Extended- Release Tablets (PDF – 156KB)96 NDA 22-104 5/20/2008 medication guide
Vibativ (telavancin) Injection (PDF – 133KB)97   NDA 22-110/S-002 9/11/2009; modified 7/27/2011 medication guide, communication plan
Victoza (liraglutide) Injection (PDF – 1025KB)98  NDA 22-341/S-004 1/25/2010; modified 5/18/2011 communication plan
Videx, Videx EC (didanosine) Delayed-Release Capsules and Oral Solution  NDA 20-156/S-047; 21-183/S-024 1/25/2010; released from REMS requirement 5/10/2011  
Viibryd (vilazodone hydrochloride) Tablets   NDA 22-567/S-002 1/21/2011; released from REMS requirement  
6/29/2011
Vimpat (lacosamide) Injection, Oral Solution, and Tablets   NDA 22-253/S-020; 22-254/S-013; 22-255/S-007 10/28/2008; modified 4/20/2010; released from REMS requirement 8/10/2011  
Viramune (nevirapine) Tablets, Oral Suspension, and Extended-Release Tablets   NDA 20-636/S-038; 20-933/S-029; 201152/S-001 6/24/2008; modified 1/13/2010, 7/20/2010, 1/7/2011, 3/25/2011; released from REMS requirement 5/6/2011  
Visicol (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets (PDF – 28KB)99 NDA 21-097/S-014 10/13/2009 medication guide, communication plan
Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF – 27KB)100  NDA 21-897/S-015 3/22/2010; modified 10/12/2010 medication guide
Votrient (pazopanib) Tablets    NDA 22-465/S-006 10/19/2009; modified 4/27/2010; released from REMS requirement 4/21/2011  
Wellbutrin, Wellbutrin SR (bupropion hydrochloride) Tablets and Sustained-Release Tablets (PDF – 124KB)101 NDA 18-644/S-041; 20-358/S-048 2/26/2010 medication guide
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets (PDF – 92KB)102 NDA 21-515/S-025 2/26/2010 medication guide
Xenazine (tetrabenazine) Tablets (PDF – 2837KB)103    NDA 21-894/S-005 8/15/2008; modified 12/1/2009, 5/4/2011 medication guide, communication plan
Xeomin (incobotulinumtoxinA) Injection (PDF -49KB)104   BLA 125360/7 7/30/2010; modified 7/20/2011 communication plan
Xiaflex (collagenase clostridium histolyticum) Injection (PDF – 2290KB)105 BLA 125338 2/2/2010 medication guide, communication plan
Xolair (omalizumab) Injection (PDF – 50KB)106 BLA 103976/5180 7/24/2009; modified 12/21/2010 medication guide
Yervoy (ipilimumab) Injection (PDF – 31KB)107  BLA 125377 3/25/2011 communication plan
Zarontin (ethosuximide) Capsules  NDA 12-380/S-033 9/14/2010; released from REMS requirement 6/15/2011  
Zenpep (pancrelipase) Delayed-Release Capsules   NDA 22-210/S-008 8/27/2009; released from REMS requirement 6/10/2011  
Zerit (stavudine) Capsules and Oral Solution   NDA 20-412/S-037; 20-413/S-029 12/10/2010; released from REMS requirement 5/11/2011  
Ziagen (abacavir sulfate) Tablets and Oral Solution  NDA 20-977/S-022; 20-978/S-026 7/18/2008; modified 8/4/2010; released from REMS requirement 5/13/2011  
Zipsor (diclofenac potassium) Capsules   NDA 22-202/S-003, S-004 6/16/2009; released from REMS requirement 5/4/2011  
Zolpimist (zolpidem tartrate) Oral Spray   NDA 22-196/S-007 12/19/2008; modified 10/11/2010; released from REMS requirement 9/28/2011  
Zonegran (zonisamide) Capsules NDA 20-789/S-029 4/23/2009; modified 4/19/2010; released from REMS requirement 5/27/2011  
Zortress (everolimus) Tablets (PDF – 161KB)108 NDA 21-560 4/20/2010 medication guide, communication plan
Zyban (bupropion hydrochloride) Sustained-Release Tablets (PDF – 97KB)109 NDA 20-711/S-034 2/26/2010 medication guide
Zyprexa, Zyprexa Zydis (olanzapine) Tablets   NDA 20-592/S-060, S-061; 21-086/S-038, S-039 3/19/2009; modified 12/4/2009; released from REMS requirement 6/21/2011  
Zyprexa Relprevv (olanzapine) Extended-Release Injection (PDF -98KB)110  NDA 22-173/S-004 12/11/2009; modified 7/8/2010 medication guide, communication plan, elements to assure safe use, implementation system