| Name | Application | Date REMS Approved | REMS Components(All REMS include timetable for assessment) |
|---|---|---|---|
| Actemra (tocilizumab) Injection (PDF – 456KB) | BLA 125276/0 | 1/8/2010 | medication guide, communication plan |
| Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets (PDF – 13KB) | NDA 21-842/S-011, 22-024 | 9/14/2009; modified 10/21/2009 | medication guide |
| Actoplus Met XR (pioglitazone and metformin) Extended-Release Tablets (PDF – 79KB) | NDA 22-024 | 5/12/2009 | medication guide |
| Actos (pioglitazone hydrochloride) Tablets (PDF – 61KB) | NDA 21-073/S-037 | 9/9/2009 | medication guide |
| Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) (PDF – 35KB) | NDA 21-077/S-029 | 4/30/2008 | medication guide |
| Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) (PDF – 12KB) | NDA 21-254/S-007 | 7/31/2008; modified 9/15/2009 | medication guide |
| Ampyra (dalfampridine) Extended-Release Tablets (PDF – 60KB) | NDA 22-250 | 1/22/2010 | medication guide, communication plan |
| Androgel (testosterone) Gel (PDF – 86KB) | NDA 21-015/S-022 | 9/18/2009 | medication guide |
| Aplenzin (buproprion hydrobromide) Extended-Release Tablets (PDF – 31KB) | NDA 22-108 | 4/23/2008 | medication guide |
| Aranesp (darbepoetin alfa) Injection (PDF – 11288KB) | BLA 103951/5197 | 2/16/2010 | medication guide, communication, elements to assure safe use, implementation system |
| Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets (PDF – 96KB) |
NDA 21-410/S-025 | 12/2/2008 | medication guide |
| Avandaryl (rosiglitazone maleate and glimepiride) Tablets (PDF – 96 KB) | NDA 21-700/S-008 | 12/2/2008 | medication guide |
| Avelox (moxifloxacin) Tablets and I.V. Solution (PDF – 20KB) | NDA 21-085/S-042, 21-277/S-036 | 4/27/2009 | medication guide |
| Banzel (rufinamide) Tablets (PDF – 21KB) | NDA 21-911 | 11/14/2008 | medication guide |
| Botox/Botox Cosmetic (onabotulinumtoxinA) Injection (PDF – 35KB) | BLA 103000/5189 | 7/31/2009; modified 3/9/2010 | medication guide, communication plan |
| Byetta (exanatide) Injection (PDF – 30KB) | NDA 21-773/S-009, S-011, S-017, S-018, S-022, S-025; 21-919 | 10/30/2009 | medication guide, communication plan |
| Cambia (diclofenac potassium) Oral Solution (PDF – 39KB) | NDA 22-165 | 6/17/2009 | medication guide |
| Chantix (varenicline) Tablets (PDF – 85KB) | NDA 21-928/S-014, S-017 | 10/19/2009; modified 4/22/2010 | medication guide |
| Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection (PDF – 250KB) | BLA 125160/92 | modified 12/31/2008, 5/13/2009, 11/3/2009 | medication guide, communication plan |
| Cipro (ciprofloxacin) Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets) (PDF – 19KB) | NDA 19-537/S-070, 19-847/S-044, 19-857/S-051, 20-780/S-028, 21-473/S-025 | 4/27/2009 | medication guide |
| Colcrys (colchicine) Tablets (PDF – 14KB) | NDA 22-351 | 7/30/2009 | medication guide |
| Colcrys (colchicine) Tablets (PDF – 43KB) | NDA 22-352/S-004 | 7/29/2009; modified 4/29/2010 | medication guide |
| Colcrys (colchicine) Tablets (PDF – 36KB) | NDA 22-353 | 10/16/2009 | medication guide |
| Copegus (ribavirin) Tablets (PDF – 28KB) New! | NDA 21-511/S-019 | 6/9/2010 | medication guide |
| Creon (pancrelipase) Delayed-Release Capsules (PDF – 105KB) | NDA 20-725 | 4/30/2009 | medication guide |
| Darvon Capsules, Darvon-N Tablets, and Darvocet-N (propoxyphene) Tablets (PDF – 22KB) | NDA 10-997/S-051, S-052;16-062/S-041, S-042; 17-122/S-061, S-062 | 9/25/2009 | medication guide |
| Duetact (pioglitazone hydrochloride and glimepiride) Tablets (PDF – 22KB) | NDA 21-925/S-007 | 9/9/2009 | medication guide |
| Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol (PDF – 334KB) New! | NDA 22-518 | 6/22/2010 | medication guide, communication plan |
| Dysport (abobotulinumtoxinA) Injection (PDF – 1020KB) | BLA 125274/0, 125274/1 | 4/29/2009 | medication guide, communication plan |
| Edluar (zolpidem tartrate) Sublingual Tablets (PDF – 26KB) |
NDA 21-997 | 3/13/2009 | medication guide |
| Effient (prasugrel) Tablets (PDF – 57KB) | NDA 22-307/S-001 | 7/10/2009; 4/16/2010 | medication guide, communication plan |
| Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules (PDF – 47KB) | NDA 22-321 | 8/13/2009 | medication guide, communication plan |
| Enbrel (etanercept) for Subcutaneous Injection (PDF – 35KB) Updated! | BLA 103795/5391, 5397, 5400 | 6/23/2008; modified 6/3/2010 | medication guide, communication plan |
| Entereg (alvimopan) Capsules (PDF – 2120KB) | NDA 21-775 | modified 2/5/2009 | communication plan, elements to assure safe use, implementation system |
| Epogen/Procrit (epoetin alfa) Injection (PDF – 11181KB) | BLA 103234/5199 | 2/16/2010 | medication guide, communication, elements to assure safe use, implementation system |
| Epzicom (abacavir sulfate and lamivudine) Tablets (PDF – 66KB) | NDA 21-652/S-008 | 3/9/2009 | medication guide |
| Exalgo (hydromorphone hydrochloride) Extended-Release Tablets (PDF – 1660KB) | NDA 21-217 | 3/1/2010; modified 3/24/2010 | medication guide, elements to assure safe use |
| Extavia (interferon beta-1b) (PDF – 47KB) | BLA 125290/0 | 8/14/2009 | medication guide |
| Factive (gemifloxacin) Tablets (PDF – 48KB) | NDA 21-158/S-014 | 4/27/2009 | medication guide |
| Forteo (teriparatide [rDNA origin]) Injection (PDF – 115KB) | NDA 21-318/S-012 | 7/22/2009 | medication guide, communication plan |
| Infergen (interferon alfacon-1) (PDF – 77KB) | BLA 103663/5074 | 8/7/2009 | medication guide |
| Intron A (interferon alfa-2b) (PDF – 61KB) | BLA 103132/5122, 103132/5108 | 5/2/2008; modified 8/7/2009 | medication guide |
| Janumet (sitagliptin/metformin) Tablets (PDF – 21KB) | NDA 22-044/S-010, S-012, S-013 | 2/26/2010 | medication guide |
| Januvia (sitagliptin) Tablets (PDF – 21KB) | NDA 21-995/S-010, S-011, S-012, S-014 | 2/26/2010 | medication guide |
| Kalbitor (ecallentide) Injection (PDF – 355KB) | BLA 125277 | 12/1/2009 | medication guide, communication plan |
| Kaletra (lopinavir and ritonavir) Tablets and Oral Solution (PDF – 187KB) Updated! | NDA 21-906/S-026, 21-251/S-033 | 4/6/2009; modified 1/29/2010, 4/27/2010, 6/14/2010 | medication guide |
| Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection (PDF – 36KB) | NDA 21-035/S-078, S-080, 21-505/S-021, S-024 | 4/23/2009 | medication guide |
| Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets (ODT) (PDF – 33KB) | NDA 20-241, 20-764, 22-251 | 4/23/2009, 5/8/2009, and 5/29/2009 | medication guide |
| Lamictal (lamotrigine) Extended-Release Tablets (PDF – 35KB) | NDA 22-115/S-001, S-005 | 5/29/2009; modified 1/29/2010 4/14/2010 | medication guide |
| Lariam (mefloquine hydrochloride) Tablets (PDF – 15KB) | NDA 19-591/S-026, 19-591/S-028 | 8/20/2009 | medication guide |
| Letairis (ambrisentan) Tablets (PDF – 1120KB) | NDA 22-081/S-010 | 5/29/2009; modified 7/1/2009 and 8/5/2009 | medication guide, elements to assure safe use, implementation system |
| Levaquin (levofloxacin) Tablets, Injection, and Oral Solution (PDF – 34KB) | NDA 20-634/ S-053, 20-635/ S-058, 21-721/ S-021 | 4/27/2009 | medication guide |
| Lumizyme (alglucosidase alfa) (PDF – 71KB) | BLA 125291 | 5/24/2010 | communication plan, elements to assure safe use, implementation system |
| Lyrica (pregabalin) Capsules and Oral Solution (PDF – 35KB) | NDA 22-488, 21-446/S-018 | 2/23/2009; modified 1/4/2010 | medication guide |
| Metoclopramide Oral Solution (PDF – 24KB) | ANDA 73-680/S-018 | 9/11/2009 | medication guide |
| Metoclopramide Oral Solution (PDF – 31KB) | ANDA 74-703/S-007 | 9/15/2009 | medication guide |
| Metoclopramide Oral Solution (PDF – 24KB) | ANDA 72-744/S-011 | 9/15/2009 | medication guide |
| Metoclopramide Oral Solution (PDF – 24KB) | NDA 71-402/S-008 | 9/16/2009 | medication guide |
| Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets (PDF – 21KB) | NDA 22-246 | 9/4/2009 | medication guide |
| Morphine Sulfate Oral Solution (PDF – 25KB) | NDA 22-195/S-002 | 1/25/2010 | medication guide |
| Multaq (dronedarone) Tablets (PDF – 294KB) | NDA 22-425 | 7/1/2009 | medication guide, communication plan |
| Myobloc (rimabotulinumtoxinB) Injection (PDF – 361KB) | BLA 103846/5120 | 7/31/2009 | medication guide, communication plan |
| Noroxin (norfloxacin) Tablets (PDF – 22KB) | NDA 19-384/S-054 | 4/27/2009 | medication guide |
| Nplate (romiplostim) for Subcutaneous Injection (PDF – 436KB) | BLA 125268/28, 36 | 8/22/2008; modified 8/14/2009, 3/23/2010 | medication guide, communication plan, elements to assure safe use, implementation system |
| Oleptro (trazadone hydrochloride) Extended-Release Tablets (PDF- 18KB) | NDA 22-411 | 2/2/2010 | medication guide |
| Onsolis (fentanyl buccal soluble film) (PDF – 4960KB) | NDA 22-266 | 7/16/2009 | medication guide, communication plan, elements to assure safe use, implementation system |
| Osmoprep (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets (PDF – 28KB) | NDA 21-892/S-004 | 10/13/2009 | medication guide, communication plan |
| Oxycontin (oxycodone hydrochloride) Controlled-Release Tablets (PDF – 288KB) | NDA 22-272 | 4/5/2010 | medication guide, elements to assure safe use |
| Pancreaze (pancrelipase) Delayed-Release Capsules (PDF – 35KB) | NDA 22-523 | 4/12/2010 | medication guide |
| Peganone (ethotoin) Tablets (PDF – 126KB) New! | NDA 10-841/S-022 | 6/7/2010 | medication guide |
| Pegasys (peginterferon alfa-2a) (PDF – 17KB) Updated! | BLA 103964/5176 | 10/31/2008; modified 8/7/2009, 5/24/2010 | medication guide |
| PegIntron (peginterferon alfa-2b) (PDF – 57KB) | BLA 103949/5183 | 12/11/2008; modified 8/7/2009 | medication guide |
| PegIntron Rebetol Combopack (Peginterferon alfa-2b, Redipen Single-dose Delivery System and Rebetol Ribavirin) (PDF – 512KB) | BLA 125196/0 | 6/13/2008 | medication guide |
| Pennsaid (diclofenac sodium) Topical Solution (PDF – 22KB) | NDA 20-947/S-002 | 11/4/2009; modified 3/25/2010 | medication guide |
| Prolia (denosumab) Injection (PDF – 187KB) | BLA 125320 | 6/1/2010 | medication guide, communication plan |
| Promacta (eltrombopag) Tablets (PDF – 4180KB) | NDA 22-291/S-003 | 11/20/2008; modified 3/5/2010 | medication guide, elements to assure safe use, implementation system |
| Propylthiouracil (propylthiouracil) Tablets (PDF – 18KB) | NDA 06-188/S-020 | 4/1/2010 | medication guide |
| Proquin XR (ciprofloxacin) Extended-Release Tablets (PDF – 23KB) | NDA 21-744/S-012 | 4/27/2009 | medication guide |
| Qualaquin (quinine sulfate) Capsules (PDF – 161KB) New! | NDA 21-799/S-011 | 6/15/2010 | medication guide, communication plan |
| Rebetol (ribivarin) Capsules (PDF – 66KB) | NDA 20-903/S-042, S-043, S-044, S-045; 21-546/S-001 | 11/6/2009 | medication guide |
| Reglan ODT (metoclorpramide hydrochloride) Orally Disintegrating Tablets (PDF – 42KB) | NDA 21-793/S-005 | 9/4/2009 | medication guide |
| Reglan (metoclopramide hydrochloride) Tablets (PDF – 13KB) | NDA 17-854/S-052 | 9/4/2009 | medication guide |
| Remicade (infliximab) Vial (PDF – 252KB) | BLA 103772/5258 | 11/18/2009 | medication guide, communication plan |
| Rozerem (ramelteon) Tablets (PDF – 27KB) | NDA 21-782/S-008, S-009, S-010 | 10/20/2008 | medication guide |
| Sabril (vigabatrin) Tablets and Oral Solution (PDF – 1460KB) | NDA 22-006, NDA 20-427 | 8/21/2009 | medication guide, communication plan, elements to assure safe use, implementation system |
| Samsca (tolvaptan) Tablets (PDF – 305KB) | NDA 22-275 | 5/19/2009 | medication guide, communication plan |
| Savella (milnacipran hydrochloride) Tablets (PDF – 56KB) |
NDA 22-256/S-004 | 1/14/2009; modified 2/2/2010 | medication guide |
| Seroquel (quetiapine) Tablets (PDF – 19KB) | NDA 20-639/S-045, S-046 | 12/2/2009 | medication guide |
| Seroquel XR (quetiapine) Extended-Release Tablets (PDF – 19KB) | NDA 22-047/S-011, S-016, S-017, S-019, S-022 | 12/2/2009 | medication guide |
| Simponi (golimumab) Injection (PDF – 164KB) | BLA 125289/6 | 4/24/2009; modified 11/3/2009 | medication guide, communication plan |
| Silenor (doxepin) Tablets (PDF – 60KB) | NDA 22-036 | 3/17/2010 | medication guide |
| Soliris (eculizumab) Injection (PDF – 981KB) New! | BLA 125166/44 | 6/4/2010 | medication guide, elements to assure safe use |
| Stelara (ustekinumab) Injection (PDF – 1763KB) | BLA 125261/1 | 9/25/2009; modified 12/30/2009 | medication guide, communication plan |
| Sucraid (sacrosidase) Oral Solution (PDF – 100KB) | NDA 20-772/S-005 | 11/20/2008 | communication plan, elements to assure safe use, implementation system |
| Symbicort (budesonide and formoterol) Inhalation Aerosol) (PDF – 86KB) | NDA 21-929/S-012 | 2/27/2009 | medication guide |
| Symbyax (olanzapine and fluoxetine) Capsules (PDF – 10KB) | NDA 21-520/S-012 | 3/19/2009 | medication guide |
| Tapentadol Tablets (PDF – 222KB) | NDA 22-304 | 11/20/2008 | medication guide |
| Tasigna (nilotinib) Capsules (PDF – 6273KB) Updated! | NDA 22-068/S-004 | 3/15/2010; modified 6/17/2010 | medication guide, communication plan |
| Testim (testosterone) Gel (PDF – 22KB) | NDA 21-454/S-008 | 9/18/2009 | medication guide |
| Topamax (topiramate) Tablets and Sprinkle Capsules (PDF – 212KB) | NDA 20-505/S-038, S-039, 20-844/S-032, S-034 | 4/23/2009 | medication guide |
| Tracleer (bosentan) Tablets (PDF – 1000KB) | 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 (PDF – 44KB) New! | NDA 17-105/S-076 | 6/7/2010 | medication guide |
| Treximet (sumatriptan succinate and naproxen sodium) Tablets (PDF – 112KB) | NDA 21-926 | 4/15/2008 | medication guide |
| Trilipix (fenofibric acid) Delayed-Release Capsules (PDF – 91KB) | NDA 22-224 | 12/15/2008 | medication guide |
| Trizivir (abacavir sulfate, lamivudine, and zidovudine) (PDF – 66KB) | NDA 21-205/S-021 | 3/9/2009 | medication guide |
| Tyzeka (telbivudine) Oral Solution (PDF – 119KB) | NDA 22-154 | 4/28/2009 | medication guide |
| Tyzeka (telbivudine) Tablets (PDF – 34KB) | NDA 22-011/S-001 | 1/23/2009 | medication guide |
| Venlafaxine hydrochloride Extended- Release Tablets (PDF – 156KB) | NDA 22-104 | 5/20/2008 | medication guide |
| Vibativ (telavancin) Injection (PDF – 57KB) | NDA 22-110 | 9/11/2009 | medication guide, communication plan |
| Victoza (liraglutide) Injection (PDF – 141KB) | NDA 22-341 | 1/25/2010 | medication guide, communication plan |
| Videx, Videx EC (didanosine) Delayed-Release Capsules and Oral Solution (PDF – 136KB) | NDA 20-156/S-046, NDA 21-183/S-023 | 1/25/2010 | medication guide |
| Vimpat (lacosamide) Injection, Oral Solution, and Tablets (PDF – 35KB) | NDA 22-253/S-006, NDA 22-254/S-003, NDA 22-255 | 10/28/2008; modified 4/20/2010 | medication guide |
| Viramune (nevirapine) Tablets and Oral Suspension (PDF – 16KB) | NDA 20-636/S-032; 20-933/S-022 | 6/24/2008; modified 1/13/2010 | medication guide |
| Visicol (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets (PDF – 28KB) | NDA 21-097/S-014 | 10/13/2009 | medication guide, communication plan |
| Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF – 55KB) | NDA 21-897/S-005, S-010 | 3/22/2010 | medication guide |
| Votrient (pazopanib) Tablets (PDF – 17KB) | NDA 22-465 | 10/19/2009 | medication guide |
| Wellbutrin, Wellbutrin SR (bupropion hydrochloride) Tablets and Sustained-Release Tablets (PDF – 124KB) | NDA 18-644/S-041, NDA 20-358/S-048 | 2/26/2010 | medication guide |
| Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets (PDF – 92KB) | NDA 21-515/S-025 | 2/26/2010 | medication guide |
| Xenazine (tetrabenazine) Tablets (PDF – 57KB) | NDA 21-894/S-001, S-002 | 8/15/2008; modified 12/1/2009 | medication guide, communication plan |
| Xiaflex (collagenase clostridium histolyticum) Injection (PDF – 2290KB) | BLA 125338 | 2/2/1010 | medication guide, communication plan |
| Xolair (omalizumab) Injection (PDF – 135KB) | BLA 103976/5154 | 7/24/2009 | medication guide |
| Zenpep (pancrelipase) Delayed-Release Capsules (PDF – 30KB) | NDA 22-210 | 8/27/2009 | medication guide |
| Ziagen (abacavir sulfate) Tablets and Oral Solution (PDF – 83KB) | NDA 20-977/S-017, 20-978/S-020 | 7/18/2008 | medication guide |
| Zolpimist (zolpidem tartrate) Oral Spray (PDF – 12KB) |
NDA 22-196 | 12/19/2008 | medication guide |
| Zonegran (zonisamide) Capsules (PDF – 28KB) | NDA 20-789/S-024, S-026 | 4/23/2009; modified 4/19/2010 | medication guide |
| Zortress (everolimus) Tablets (PDF – 161KB) | NDA 21-560 | 4/20/2010 | medication guide, communication plan |
| Zyban (bupropion hydrochloride) Sustained-Release Tablets (PDF – 97KB) | NDA 20-711/S-034 | 2/26/2010 | medication guide |
| Zyprexa, Zyprexa Zydis (olanzapine) Tablets (PDF – 41KB) | NDA 20-592/S-040, S-041; 21-086 | 3/19/2009; modified 12/4/2009 | medication guide |
| Zyprexa Relprevv (olanzapine) Extended-Release Injection (PDF – 2MB)* | NDA 22-173 | 12/11/2009 | medication guide, communication, elements to assure safe use, implementation system |