Released REMS
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) Tablets | 7/1/2011 |
| 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 Tablets | 8/3/2011 |
| 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 Tablets | 8/10/2011 |
| 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 | 4/14/2011 |
| Kalbitor (ecallentide) Injection | 4/10/2013 |
| Kaletra (lopinavir and ritonavir) Tablets and Oral Solution | 5/6/2011 |
| Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection | 8/10/2011 |
| Ketek (telithromycin) Tablets | 6/20/2011 |
| 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 Tablets | 4/25/2011 |
| Lariam (mefloquine hydrochloride) Tablets | 4/29/2011 |
| Levaquin (levofloxacin) Tablets, Injection, and Oral Solution | 10/7/2011 |
| Lyrica (pregabalin) Capsules and Oral Solution | 4/26/2011 |
| Lumizyme (aglucosidase alfa) (BLA 125291) | 8/1/2014 |
| Metoclopramide Oral Solution (ANDA 73-680) | 3/14/2012 |
| Metoclopramide Oral Solution (ANDA 72-744) | 9/10/2012 |
| Metoclopramide Oral Solution (ANDA 71-402) | 7/31/2012 |
| Metoclopramide Oral Solution (ANDA 74-703) | 4/08/2014 |
| Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets | 8/22/2011 |
| Morphine Sulfate Oral Solution | 10/18/2011 |
| 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 tablets | 7/11/2013 |
| 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) Tablets | 12/9/2011 |
| Oxycodone Hydrochloride Oral Solution | 1/25/2012 |
| Pancreaze (pancrelipase) Delayed-Release Capsules | 6/20/2011 |
| 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 | 4/5/2011 |
| Promacta (eltrombopag)Tablets | 7/16/2014 |
| 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 | 4/26/2011 |
| Serevent Diskus (salmeterol xinafoate) Inhalation Powder | 8/9/2012 |
| Seroquel (quetiapine) Tablets | 11/9/2011 |
| 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 Capsules | 6/10/2011 |
| Zerit (stavudine) Capsules and Oral Solution | 5/11/2011 |
| Ziagen (abacavir sulfate) Tablets and Oral Solution | 5/13/2011 |
| Zipsor (diclofenac potassium) Capsules | 5/4/2011 |
| Zolpimist (zolpidem tartrate) Oral Spray | 9/28/2011 |
| Zonegran (zonisamide) Capsules | 5/27/2011 |
| Zortress (everolimus) Tablets | 5/2/2012 |
| Zyprexa, Zyprexa Zydis (olanzapine) Tablets | 6/21/2011 |