Approved Risk Evaluation and Mitigation Strategies (REMS)

   

Name	Application	Date REMS Approved	REMS Components (All REMS include timetable for assessment)
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets [PDF]	NDA 21-842/S-009	9/14/2009	medication guide
Actoplus Met XR (pioglitazone and metformin) Extended-Release Tablets [PDF]	NDA 22-024	5/12/2009	medication guide
Actos (pioglitazone hydrochloride) Tablets [PDF]	NDA 21-073/S-037	9/9/2009	medication guide
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) [PDF]	NDA 21-077/S-029	4/30/2008	medication guide
Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) [PDF]	NDA 21-254/S-007	7/31/2008; modified 9/15/2009	medication guide
Androgel (testosterone) Gel [PDF]  New!	NDA 21-015/S-022	9/18/2009	medication guide
Aplenzin (buproprion hydrobromide) Extended-Release Tablets [PDF]	NDA 22-108	4/23/2008	medication guide
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets [PDF]	NDA 21-410/S-025	12/2/2008	medication guide
Avandaryl (rosiglitazone maleate and glimepiride) Tablets [PDF]	NDA 21-700/S-008	12/2/2008	medication guide
Avelox (moxifloxacin) Tablets and I.V. Solution [PDF]	NDA 21-085/S-042, 21-277/S-036	4/27/2009	medication guide
Banzel (rufinamide) Tablets [PDF]	NDA 21-911	11/14/2008	medication guide
Botox/Botox Cosmetic (onabotulinumtoxinA) Injection [PDF]	BLA 103000/5210, 5209	7/31/2009	medication guide, communication plan
Cambia (diclofenac potassium) Oral Solution [PDF]	NDA 22-165	6/17/2009	medication guide
Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection [PDF]	BLA 125160/0 and 125271/0	modified 12/31/2008 and 5/13/2009	medication guide, communication plan
Cipro (ciprofloxacin) Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets) [PDF]	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]	NDA 22-351	7/30/2009	medication guide
Colcrys (colchicine) Tablets [PDF]	NDA 22-352	7/29/2009	medication guide
Colcrys (colchicine) Tablets [PDF]  New!	NDA 22-353	10/16/2009	medication guide
Creon (pancrelipase) Delayed-Release Capsules [PDF]	NDA 20-725	4/30/2009	medication guide
Darvon Capsules, Darvon-N Tablets, and Darvocet-N (propoxyphene) Tablets [PDF]  New!	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]	NDA 21-925/S-007	9/9/2009	medication guide
Dysport (abobotulinumtoxinA) Injection [PDF]	BLA 125274/0, 125274/1	4/29/2009	medication guide, communication plan
Edluar (zolpidem tartrate) Sublingual Tablets [PDF]	NDA 21-997	3/13/2009	medication guide
Effient (prasugrel) Tablets [PDF]	NDA 22-307	7/10/2009	medication guide, communication plan
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules [PDF]	NDA 22-321	8/13/2009	medication guide, communication plan
Enbrel (etanercept) for Subcutaneous Injection [PDF]	BLA 103795/5359	6/23/2008	medication guide
Entereg (alvimopan) Capsules [PDF]	NDA 21-775	modified 2/5/2009	communication plan, elements to assure safe use, implementation system
Epzicom (abacavir sulfate and lamivudine) Tablets  [PDF]	NDA 21-652/S-008	3/9/2009	medication guide
Extavia (interferon beta-1b) [PDF]	BLA 125290/0	8/14/2009	medication guide
Factive (gemifloxacin) Tablets [PDF]	NDA 21-158/S-014	4/27/2009	medication guide
Forteo (teriparatide [rDNA origin]) Injection [PDF]	NDA 21-318/S-012	7/22/2009	medication guide, communication plan
Infergen (interferon alfacon-1) [PDF]	BLA 103663/5074	8/7/2009	medication guide
Intron A (interferon alfa-2a) [PDF]	BLA 103132/5122, 103132/5108	5/2/2008; modified 8/7/2009	medication guide
Kaletra (lopinavir and ritonavir) Oral Solution [PDF]	NDA 21-906/S-014, 21-251/S-023	4/6/2009	medication guide
Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection [PDF]	NDA 21-035/S-078, S-080, 21-505/S-021, S-024	4/23/2009	medication guide
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets (ODT), and Extended-Release Tablets (XR) [PDF]	NDA 20-241, 20-764, 22-251, 22-115	4/23/2009, 5/8/2009, and 5/29/2009	medication guide
Lariam (mefloquine hydrochloride) Tablets [PDF]	NDA 19-591/S-026, 19-591/S-028	8/20/2009	medication guide
Letairis (ambrisentan) Tablets [PDF]	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]	NDA 20-634/ S-053, 20-635/ S-058, 21-721/ S-021	4/27/2009	medication guide
Lyrica (pregabalin) Capsules [PDF]	NDA 21-446/S-013, S-014	4/23/2009	medication guide
Metoclopramide Oral Solution [PDF]	ANDA 73-680/S-018	9/11/2009	medication guide
Metoclopramide Oral Solution [PDF]	ANDA 74-703/S-007	9/15/2009	medication guide
Metoclopramide Oral Solution [PDF]	ANDA 72-744/S-011	9/15/2009	medication guide
Metoclopramide Oral Solution [PDF]	NDA 71-402/S-008	9/16/2009	medication guide
Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets [PDF]	NDA 22-246	9/4/2009	medication guide
Multaq (dronedarone) Tablets [PDF]	NDA 22-425	7/1/2009	medication guide, communication plan
Myobloc (rimabotulinumtoxinB) Injection	BLA 103846/5120	7/31/2009	medication guide, communication plan
Noroxin (norfloxacin) Tablets [PDF]	NDA 19-384/S-054	4/27/2009	medication guide
Nplate (romiplostim) for Subcutaneous Injection [PDF]	BLA 125268	8/22/2008; modified 8/14/2009	medication guide, communication plan, elements to assure safe use, implementation system
Onsolis (fentanyl buccal soluble film) [PDF]	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]  New!	NDA 21-892/S-004	10/13/2009	medication guide, communication plan
Pegasys (peginterferon alfa-2a) [PDF]	BLA 103964	modified 8/7/2009	medication guide
PegIntron (peginterferon alfa-2b) [PDF]	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]	BLA 125196/0	6/13/2008	medication guide
Promacta (eltrombopag) Tablets [PDF]	NDA 22-291	11/20/2008	medication guide, elements to assure safe use, implementation system
Proquin XR (ciprofloxacin) Extended-Release Tablets [PDF]	NDA 21-744/S-012	4/27/2009	medication guide
Reglan ODT (metoclorpramide hydrochloride) Orally Disintegrating Tablets [PDF]	NDA 21-793/S-005	9/4/2009	medication guide
Reglan (metoclopramide hydrochloride) Tablets [PDF]	NDA 17-854/S-052	9/4/2009	medication guide
Rozerem (ramelteon) Tablets [PDF]	NDA 21-782/S-008, S-009, S-010	10/20/2008	medication guide
Sabril (vigabatrin) Tablets and Oral Solution [PDF]	NDA 22-006, NDA 20-427	8/21/2009	medication guide, communication plan, elements to assure safe use, implementation system
Samsca (tolvaptan) Tablets [PDF]	NDA 22-275	5/19/2009	medication guide, communication plan
Savella (milnacipran hydrochloride) Tablets [PDF]	NDA 22-256	1/14/2009	medication guide
Simponi (golimumab) Injection [PDF]	BLA 125289	4/24/2009	medication guide, communication plan
Stelara (ustekinumab) Injection* [PDF]  New!	BLA 125261	9/25/2009	medication guide, communication plan
Sucraid (sacrosidase) Oral Solution [PDF]	NDA 20-772/S-005	11/20/2008	communication plan, elements to assure safe use, implementation system
Symbicort (budesonide and formoterol) Inhalation Aerosol) [PDF]	NDA 21-929/S-012	2/27/2009	medication gude
Symbyax (olanzapine and fluoxetine) Capsules [PDF]	NDA 21-520/S-012	3/19/2009	medication guide
Tapentadol Tablets [PDF]	NDA 22-304	11/20/2008	medication guide
Testim (testosterone) Gel [PDF]  New!	NDA 21-454/S-008	9/18/2009	medication guide
Topamax (topiramate) Tablets and Sprinkle Capsules [PDF]	NDA 20-505/S-038, S-039, 20-844/S-032, S-034	4/23/2009	medication guide
Tracleer (bosentan) Tablets [PDF]	NDA 21-290/S-016	8/7/2009	medication guide, elements to assure safe use, implementation system
Treximet (sumatriptan succinate and naproxen sodium) Tablets [PDF]	NDA 21-926	4/15/2008	medication guide
Trilipix (fenofibric acid) Delayed-Release Capsules [PDF]	NDA 22-224	12/15/2008	medication guide
Trizivir (abacavir sulfate, lamivudine, and zidovudine) [PDF]	NDA 21-205/S-021	3/9/2009	medication guide
Tyzeka (telbivudine) Oral Solution [PDF]	NDA 22-154	4/28/2009	medication guide
Tyzeka (telbivudine) Tablets [PDF]	NDA 22-011/S-001	1/23/2009	medication guide
Venlafaxine hydrochloride Extended- Release Tablets [PDF]	NDA 22-104	5/20/2008	medication guide
Vibativ (telavancin) Injection [PDF]	NDA 22-110	9/11/2009	medication guide, communication plan
Vimpat (lacosamide) Injection [PDF]	NDA 22-253, 22-254	10/28/2008	medication guide
Viramune (nevirapine) Tablets and Oral Suspension [PDF]	NDA 20-636/S-027; 20-933/S-017	6/24/2008	medication guide
Visicol (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets [PDF]  New!	NDA 21-097/S-014	10/13/2009	medication guide, communication plan
Votrient (pazopanib) Tablets [PDF]  New!	NDA 22-465	10/19/2009	medication guide
Xenazine (tetrabenazine) Tablets [PDF]	NDA 21-894	8/15/2008	medication guide, communication plan
Xolair (omalizumab) Injection [PDF]	BLA 103976/5154	7/24/2009	medication guide
Zenpep (pancrelipase) Delayed-Release Capsules [PDF]	NDA 22-210	8/27/2009	medication guide
Ziagen (abacavir sulfate) Tablets and Oral Solution [PDF]	NDA 20-977/S-017, 20-978/S-020	7/18/2008	medication guide
Zolpimist (zolpidem tartrate) Oral Spray [PDF]	NDA 22-196	12/19/2008	medication guide
Zonegran (zonisamide) Capsules [PDF]	NDA 20-789/S-022, S-025	4/23/2009	medication guide
Zyprexa, Zyprexa Zydis (olanzapine) Tablets [PDF]	NDA 20-592/S-039, 21-086/S-021	3/19/2009	medication guide

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