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  5. Released REMS
  1. Postmarket Drug Safety Information for Patients and Providers

Released REMS


Date Released from REMS Requirement
Actonel (risedronate sodium) Tablets  8/22/2011
Actonel with Calcium (risedronate sodium and calcium carbonate) Tablets  8/22/2011
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets  5/17/2012
Actoplus Met XR (pioglitazone and metformin) Extended-Release Tablets  5/17/2012
Actos (pioglitazone hydrochloride) Tablets  5/17/2012
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) 8/9/2012
Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) 8/9/2012
Ampyra (dalfampridine) Extended-Release Tablets 6/18/2013
Aplenzin (buproprion hydrobromide) Extended-Release Tablets  4/29/2011
Arcapta Neohaler (indacaterol maleate) Inhalation Powder 12/18/2012
Atelvia (risedronate sodium) Delayed-Release Tablets   8/22/2011
Avelox (moxifloxacin) Tablets and I.V. Solution  8/3/2011
Banzel (rufinamide) Tablets and Oral Suspension  6/10/2011
Boniva (ibandronate sodium) Injection  7/1/2011
Boniva (ibandronate sodium) Tablets7/1/2011
Botox/Botox Cosmetic (onabotulinumtoxinA) Injection  7/16/2012
Brilinta (ticagrelor) Tablets 10/30/2013
Brovana (arformoterol tartrate) Inhalation Solution 8/9/2012
Bydureon (exenatide) Extended-Release for Injectable Suspension  4/29/2015
Byetta (exanatide) Injection  8/5/2011
Cambia (diclofenac potassium) Oral Solution  7/20/2011
Carbatrol (carbamazepine) Extended-Release Capsules   8/22/2011
Celontin (methsuximide) Capsules  6/15/2011
Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection 7/26/2011
Cipro (ciprofloxacin) Tablets, Oral Suspension, I.V. Solution , and Extended-Release Tablets8/3/2011
Colcrys (colchicine) Tablets  7/20/2011
Colcrys (colchicine) Tablets  7/20/2011
Colcrys (colchicine) Tablets 7/20/2011
Copegus (ribavirin) Tablets   5/9/2011
Creon (pancrelipase) Delayed-Release Capsules  5/9/2011
Dilantin (phenytoin) Oral Suspension  5/27/2011
Duetact (pioglitazone hydrochloride and glimepiride) Tablets  5/17/2012
Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol 11/27/2012
Dysport (abobotulinumtoxinA) Injection 5/22/2012
Edluar (zolpidem tartrate) Sublingual Tablets8/10/2011
Effient (prasugrel) Tablets  3/23/2012
Enbrel (etanercept) for Subcutaneous Injection  8/10/11
Epzicom (abacavir sulfate and lamivudine) Tablets  5/13/2011
Equetro (carbamazepine) Extended-Release Capsules   1/27/2012
Extavia (interferon beta-1b)  6/22/2011
Factive (gemifloxacin) Tablets 8/4/2011
Foradil (formoterol fumarate) Inhalation Powder 3/29/2013
Fosamax (alendronate sodium) Oral Solution and Tablets  7/1/2011
Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets  7/1/2011
Gabitril (tiagabine hydrochloride) Tablets  1/25/2012
Gralise (gabapentin) Tablets  4/28/2011
HalfLytely Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride)7/6/2011
H.P. Acthar Gel (repository corticotropin) Injection 7/5/2012
Humira (adalimumab) Injection 12/13/2011
Infergen (interferon alfacon-1)  6/1/2011
Intron A (interferon alfa-2b)  5/13/2011
Invirase (saquinavir mesylate) Capsules and Tablets  5/26/2011
Janumet (sitagliptin/metformin) Tablets 4/14/2011
Januvia (sitagliptin) Tablets 
Kalbitor (ecallentide) Injection 4/10/2013
Kaletra (lopinavir and ritonavir) Tablets and Oral Solution 
Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection   8/10/2011
Ketek (telithromycin) Tablets6/20/2011
Klonopin (clonazepam) Tablets and Orally Disintegrating Tablets  11/29/2011
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets (ODT)  5/31/2011
Lamictal XR (lamotrigine) Extended-Release Tablets4/25/2011
Lariam (mefloquine hydrochloride) Tablets  4/29/2011
Levaquin (levofloxacin) Tablets, Injection, and Oral Solution  10/7/2011
Lyrica (pregabalin) Capsules and Oral Solution 
Lumizyme (aglucosidase alfa) (BLA 125291)
Metoclopramide Oral Solution (ANDA 73-680) 
Metoclopramide Oral Solution (ANDA 72-744) 
Metoclopramide Oral Solution (ANDA 71-402) 
Metoclopramide Oral Solution (ANDA 74-703) 
Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets  8/22/2011
Morphine Sulfate Oral Solution10/18/2011
Myobloc (rimabotulinumtoxinB) Injection  6/13/2012
Mysoline (primidone) Tablets   8/10/2011
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution  8/10/2011
Noroxin (norfloxacin) Tablets 9/8/2011
Nucynta (tapentadol) immediate-release (IR) oral tablets7/11/2013
Nuvigil (armodafinil) Tablets   1/13/2012
Oleptro (trazodone hydrochloride) Extended-Release Tablets  5/11/2011
Osmoprep (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets12/9/2011
Oxycodone Hydrochloride Oral Solution 1/25/2012
Pancreaze (pancrelipase) Delayed-Release Capsules6/20/2011
Peganone (ethotoin) Tablets 5/31/2011
Pegasys (peginterferon alfa-2a)5/9/2011
PegIntron (peginterferon alfa-2b)  5/13/2011
PegIntron Rebetol Combopack (peginterferon alfa-2b, Redipen Single-dose Delivery System and Rebetol ribavirin) 8/18/2009
Pennsaid (diclofenac sodium) Topical Solution  7/14/2011
Plavix (clopidogrel bisulfate) Tablets  5/3/2011
Perforomist (formoterol fumarate) Inhalation Solution 9/25/2012
Pradaxa (dabigatran etexilate mesylate) Capsules 
Promacta (eltrombopag)Tablets7/16/2014
Propylthiouracil (propylthiouracil) Tablets  7/27/2011
Proquin XR (ciprofloxacin) Extended-Release Tablets  8/15/2011
Provigil (modafinil) Tablets   1/13/2012
Qualaquin (quinine sulfate) Capsules  5/22/2012
Rapamune (sirolimus) Oral Solution and Tablets  6/6/2011
Rebetol (ribivarin) Capsules and Oral Solution  4/19/2011
Reclast (zoledronic acid) Injection  8/15/2011
Reglan ODT (metoclorpramide hydrochloride) Orally Disintegrating Tablets  8/2/2011
Reglan (metoclopramide hydrochloride) Tablets  8/2/2011
Regranex (becaplermin)4/30/2012
Remicade (infliximab) Vial  8/1/2011
Roferon-A Interferon (alfa-2a, recombinant) Injection  6/16/2011
Rozerem (ramelteon) Tablets   8/4/2011
Samsca (tolvaptan) Tablets 9/14/2012
Savella (milnacipran hydrochloride) Tablets
Serevent Diskus (salmeterol xinafoate) Inhalation Powder 8/9/2012
Seroquel (quetiapine) Tablets11/9/2011
Seroquel XR (quetiapine) Extended-Release Tablets   11/9/2011
Silenor (doxepin) Tablets 10/30/2011
Simponi (golimumab) Injection 3/17/2011
Sucraid (sacrosidase) Oral Solution 12/9/2010
Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution  7/6/2011
Sutent (sunitinib) Capsules  5/19/2011
Symbicort (budesonide and formoterol) Inhalation Aerosol  7/23/2012
Symbyax (olanzapine and fluoxetine) Capsules  6/21/2011
Tasigna (nilotinib) Capsules 5/17/2013
Tegretol and Tegretol-XR (carbemazepine) Tablets, ChewableTablets, Suspension, and Extended-Release Tablets  10/30/2011
Topamax (topiramate) Tablets and Sprinkle Capsules  6/27/2011
Tranxene (clorazepate dipotassium) Tablets 7/19/2011
Treximet (sumatriptan succinate and naproxen sodium) Tablets  9/23/2011
Trileptal (oxcarbazepine) Tablets and Suspension  10/30/2011
Trilipix (fenofibric acid) Delayed-Release Capsules  9/30/2011
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets  5/13/2011
Tyzeka (telbivudine) Oral Solution 5/5/2011
Tyzeka (telbivudine) Tablets  5/5/2011
Venlafaxine hydrochloride Extended- Release Tablets  7/31/2012
Videx, Videx EC (didanosine) Delayed-Release Capsules and Oral Solution 5/10/2011
Viibryd (vilazodone hydrochloride) Tablets  6/29/2011
Vimpat (lacosamide) Injection, Oral Solution, and Tablets  8/10/2011
Viramune (nevirapine) Tablets, Oral Suspension, and Extended-Release Tablets  5/6/2011
Visicol (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate)Tablets 12/9/2011
Votrient (pazopanib) Tablets   4/21/2011
Wellbutrin, Wellbutrin SR (bupropion hydrochloride) Tablets and Sustained-Release Tablets 8/2/2012
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets 8/2/2012
Xarelto (Rivaroxaban) Tablets 2/12/2014
Xeomin (incobotulinumtoxinA) Injection  7/16/2012
Xolair (omalizumab) Injection  12/22/2011
Zarontin (ethosuximide) Capsules 6/15/2011
Zenpep (pancrelipase) Delayed-Release Capsules6/10/2011
Zerit (stavudine) Capsules and Oral Solution5/11/2011
Ziagen (abacavir sulfate) Tablets and Oral Solution5/13/2011
Zipsor (diclofenac potassium) Capsules5/4/2011
Zolpimist (zolpidem tartrate) Oral Spray9/28/2011
Zonegran (zonisamide) Capsules5/27/2011
Zortress (everolimus) Tablets  5/2/2012
Zyprexa, Zyprexa Zydis (olanzapine) Tablets6/21/2011


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