REMSadvisor.com » Latest News http://www.remsadvisor.com An Information Resource Site for FDA REMS Mon, 30 Jan 2012 22:59:50 +0000 http://wordpress.org/?v=2.9.1 en hourly 1 http://www.remsadvisor.com/latest-news/1768/ http://www.remsadvisor.com/latest-news/1768/#comments Mon, 30 Jan 2012 22:59:50 +0000 admin http://www.remsadvisor.com/?p=1768 Name Application Date REMS Approved  REMS Components(All REMS include timetable for assessment)  Abstral (fentanyl) Sublingual Tablets (PDF – 2MB)1  Updated! NDA 22-510/S-003 1/7/2011;
modified 12/28/2011         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  Updated! NDA 20-747/S-033 7/20/2011; modified 12/28/2011 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 – 107KB)9  NDA 22-250/S-002 1/22/2010; modified 11/17/2011 medication guide, communication plan Androgel (testosterone) Gel (PDF – 28KB)10   NDA 21-015/S-032 9/18/2009; modified 3/10/2011, 11/30/2011 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
hydrochloride) Tablets (PDF – 5MB)14   NDA 21-410/S-029 12/2/2008; modified 5/18/2011, 11/13/2011 medication guide, communication plan, elements to assure safe use, implementation system Avandaryl (rosiglitazone maleate and glimepiride) Tablets (PDF – 5MB)15   NDA 21-700/S-012 12/2/2008; modified 5/18/2011, 11/13/2011 medication guide, communication plan, elements to assure safe use, implementation system Avandia (rosiglitazone maleate) Tablets (PDF – 5MB)16   NDA 21-071/S-040 5/18/2011; modified 11/13/2011 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
6/22/2011 medication guide, communication plan, elements to assure safe use, implementation system 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  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   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  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)
Sublingual Tablets   NDA 21-997/S-003 3/13/2009; modified 12/17/2010; released from REMS requirement  8/10/2011   Effient (prasugrel) Tablets (PDF – 990KB)28   NDA 22-307/S-003 7/10/2009; modified
4/16/2010, 12/6/2010, 9/26/2011 medication guide, communication plan 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 Updated! NDA 21-947/S-013 7/20/2011; modified 12/28/2011 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 Updated! BLA 125057/271 4/8/2010; modified 3/14/2011, 7/13 2011; released from REMS requirement 12/13/2011   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)42 List of application numbers and sponsors (PDF – 21KB)43 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)44   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  Updated! NDA 17-533/S-046; 20-813/S-008 9/1/2010; released from REMS requirement 11/29/2011   Krystexxa (pegloticase) Injection (PDF – 889KB)45  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 – 2MB)46  Updated! NDA 22-569/S-005 6/30/2011; modified 11/4/2011, 12/28/2011 medication guide, elements to assure safe use, implementation system Letairis (ambrisentan) Tablets (PDF – 3562KB)47  NDA 22-081/S-017 5/29/2009; modified 7/1/2009, 
8/5/2009, 8/24/2010, 10/13/2010, 3/3/2011 medication guide, elements to assure safe use, implementation system Levaquin (levofloxacin) Tablets, Injection, and Oral Solution (PDF – 34KB)48  NDA 20-634/ S-053; 20-635/ S-058; 21-721/ S-021 4/27/2009 medication guide Lotronex (alosetron hydrochloride) Tablets (PDF – 18MB)49 NDA 21-107/S-014 9/2/2010 medication guide, elements to assure safe use, implementation system Lumizyme (alglucosidase alfa) (PDF – 3MB)50  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)51 NDA 20-632/S-034, S-035 8/4/2010 medication guide Metoclopramide Oral Solution (PDF – 24KB)52 ANDA 73-680/S-018 9/11/2009 medication guide Metoclopramide Oral Solution (PDF – 31KB)53 ANDA 74-703/S-007 9/15/2009 medication guide Metoclopramide Oral Solution (PDF – 24KB)54 ANDA 72-744/S-011 9/15/2009 medication guide Metoclopramide Oral Solution (PDF – 24KB)55 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)56  NDA 20-687/S-014 6/8/2011 medication guide, elements to assure safe use, implementation system Morphine Sulfate Oral Solution  NDA 22-195/S-005 1/25/2010; released from REMS requirement 10/18/2011   Multaq (dronedarone) Tablets (PDF – 1MB)57   NDA 22-425/S-006 7/1/2009; modified 2/11/2011, 8/5/2011 medication guide, communication plan Myobloc (rimabotulinumtoxinB) Injection (PDF – 361KB)58 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 – 45KB)59   BLA 125268/77 8/22/2008; modified 8/14/2009, 3/23/2010, 7/29/2011, 12/6/2011 communication plan Nucynta ER (tapentadol) Extended-Release Tablets (PDF – 1MB)60   NDA 200533 8/25/2011        medication guide, elements to assure safe use Nulojix (belatacept) (PDF -  946KB)61  BLA 125288 6/15/2011 medication guide, communication plan Nuvigil (armodafinil) Tablets (PDF 717KB)62 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 – 2MB)63  Updated! NDA 22-266/S-008 7/16/2009; modified 7/1/2010, 12/28/2011 medication guide, elements to assure safe use, implementation system Opana ER (oxymorphone hydrochloride) Extended-Release Tablets (PDF – 481KB)64  New! NDA 201655 12/9/2011 medication guide, elements to assure safe use, implementation system Osmoprep (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets  Updated! NDA 21-892/S-009 10/13/2009; released from REMS requirement 12/9/2011   Oxycodone Hydrochloride Oral Solution (PDF – 26KB)65 NDA 200535 10/20/2010 medication guide Oxycontin (oxycodone hydrochloride) Controlled-Release Tablets (PDF – 596KB)66  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)67 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)68  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) 69 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)70   BLA 125320/5, 6 6/1/2010; modified 9/16/2011 medication guide, communication plan Promacta (eltrombopag) Tablets (PDF – 225KB)71   NDA 22-291/S-006 11/20/2008; modified 3/5/2010, 2/25/2011, 12/6/2011 communication plan 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    NDA 21-744/S-019 4/27/2009; released from REMS requirement 8/15/2011   Provigil (modafinil) Tablets (PDF – 717KB)72 NDA 20-717/S-030, S-034, S-036 10/21/2010 medication guide, communication plan Qualaquin (quinine sulfate) Capsules (PDF – 161KB)73 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)74  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)75 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)76   NDA 22-275/S-003 5/19/2009; modified 9/23/2011 communication plan Savella (milnacipran hydrochloride)
Tablets 

NDA 22-256/S-010 1/14/2009; modified 2/2/2010; released from REMS requirement 4/26/2011   Serevent Diskus (salmeterol xinafoate) Inhalation Powder (PDF – 276KB)77   NDA 20-692/S-039 11/18/2010; modified 5/10/2011, 6/27/2011 communication plan Seroquel (quetiapine) Tablets   NDA 20-639/S-055 12/2/2009; released from REMS requirement 11/9/2011   Seroquel XR (quetiapine) Extended-Release Tablets    NDA 22-047/S-028 12/2/2009; released from REMS requirement 11/9/2011   Silenor (doxepin) Tablets  NDA 22-036/S-001 3/17/2010; released from REMS requirement 10/30/2011   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)78 BLA 125166/44 6/4/2010 medication guide, elements to assure safe use Stelara (ustekinumab) Injection (PDF – 1691KB)79  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)80 NDA 22-410 8/30/2010 medication guide, elements to assure safe use, implementation system Suboxone (buprenorphine and naloxone) Sublingual Tablets (PDF – 455KB)81  New! NDA 22-733/S-007, S-008 12/22/2011 medication guide, elements to assure safe use, implementation system Subutex (buprenorphine) Sublingual Tablets (PDF – 467KB)82  New! NDA 20-732/S-006, S-007 12/22/2011 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)83   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)84 NDA 22-304 11/20/2008 medication guide Tasigna (nilotinib) Capsules (PDF – 4MB)85  Updated! NDA 22-068/S-008, S-009 3/15/2010; modified 6/17/2010, 1/14/2011, 10/26/2011, 11/18/2011 medication guide, communication plan Tegretol and Tegretol-XR (carbemazepine) Tablets, ChewableTablets, Suspension, and Extended-Release Tablets   NDA 16-608/S-109; 18-281/S-054; 18-927/S-047; 20-234/S-039 3/3/2011; released from REMS requirement 10/30/2011   Testim (testosterone) Gel (PDF – 35KB)86   NDA 21-454/S-014 9/18/2009; modified 11/22/2011 medication guide Thalomid (thalidomide) Capsules (PDF – 5402KB)87 NDA 20-785/S-039 8/3/2010 medication guide, elements to assure safe use, implementation system Tikosyn (dofetilide) Capsules (PDF – 2MB)88   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)89 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)90  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   Tysabri (natalizumab) Intravenous Injection (PDF – 67KB)91  New! BLA 125104/570 10/7/2011 medication guide, elements to assure safe use, implementation system 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)92 (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)93 NDA 22-104 5/20/2008 medication guide Vibativ (telavancin) Injection (PDF – 133KB)94   NDA 22-110/S-002 9/11/2009; modified 7/27/2011 medication guide, communication plan Victoza (liraglutide) Injection (PDF – 1025KB)95  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  Updated! NDA 21-097/S-015 10/13/2009; released from REMS requirement 12/9/2011   Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF – 27KB)96  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)97 NDA 18-644/S-041; 20-358/S-048 2/26/2010 medication guide Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets (PDF – 92KB)98 NDA 21-515/S-025 2/26/2010 medication guide Xenazine (tetrabenazine) Tablets (PDF – 2837KB)99    NDA 21-894/S-005 8/15/2008; modified 12/1/2009, 5/4/2011 medication guide, communication plan Xeomin (incobotulinumtoxinA) Injection (PDF -49KB)100   BLA 125360/7 7/30/2010; modified 7/20/2011 communication plan Xiaflex (collagenase clostridium histolyticum) Injection (PDF – 2290KB)101 BLA 125338 2/2/2010 medication guide, communication plan Xolair (omalizumab) Injection  Updated! BLA 103976/5191 7/24/2009; modified 12/21/2010; released from REMS requirement 12/22/2011   Yervoy (ipilimumab) Injection (PDF – 31KB)102  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 – 132KB)103   NDA 21-560/S-004
  4/20/2010; modified 11/21/2011 communication plan Zyban (bupropion hydrochloride) Sustained-Release Tablets (PDF – 97KB)104 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)105  NDA 22-173/S-004 12/11/2009; modified 7/8/2010 medication guide, communication plan, elements to assure safe use, implementation system ]]> http://www.remsadvisor.com/latest-news/1768/feed/ 0 FDA approves new treatment for most common type of skin cancer http://www.remsadvisor.com/latest-news/fda-approves-new-treatment-for-most-common-type-of-skin-cancer/ http://www.remsadvisor.com/latest-news/fda-approves-new-treatment-for-most-common-type-of-skin-cancer/#comments Mon, 30 Jan 2012 20:12:27 +0000 admin http://www.remsadvisor.com/latest-news/fda-approves-new-treatment-for-most-common-type-of-skin-cancer/ Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

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]]> http://www.remsadvisor.com/latest-news/fda-approves-new-treatment-for-most-common-type-of-skin-cancer/feed/ 0 FDA approves Inlyta to treat patients with a type of advanced kidney cancer http://www.remsadvisor.com/latest-news/fda-approves-inlyta-to-treat-patients-with-a-type-of-advanced-kidney-cancer/ http://www.remsadvisor.com/latest-news/fda-approves-inlyta-to-treat-patients-with-a-type-of-advanced-kidney-cancer/#comments Fri, 27 Jan 2012 20:10:24 +0000 admin http://www.remsadvisor.com/?p=1764 Drug helps keep cancer from progressing

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

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]]> http://www.remsadvisor.com/latest-news/fda-approves-inlyta-to-treat-patients-with-a-type-of-advanced-kidney-cancer/feed/ 0 FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri http://www.remsadvisor.com/latest-news/fda-permits-marketing-of-first-test-for-risk-of-rare-brain-infection-in-some-people-treated-with-tysabri/ http://www.remsadvisor.com/latest-news/fda-permits-marketing-of-first-test-for-risk-of-rare-brain-infection-in-some-people-treated-with-tysabri/#comments Fri, 20 Jan 2012 20:09:14 +0000 admin http://www.remsadvisor.com/latest-news/fda-permits-marketing-of-first-test-for-risk-of-rare-brain-infection-in-some-people-treated-with-tysabri/ Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients.

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]]> http://www.remsadvisor.com/latest-news/fda-permits-marketing-of-first-test-for-risk-of-rare-brain-infection-in-some-people-treated-with-tysabri/feed/ 0 FDA approves Voraxaze to treat patients with toxic methotrexate levels http://www.remsadvisor.com/latest-news/fda-approves-voraxaze-to-treat-patients-with-toxic-methotrexate-levels/ http://www.remsadvisor.com/latest-news/fda-approves-voraxaze-to-treat-patients-with-toxic-methotrexate-levels/#comments Tue, 17 Jan 2012 20:07:59 +0000 admin http://www.remsadvisor.com/?p=1761 Helps lower high blood levels of the chemotherapy drug

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

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]]> http://www.remsadvisor.com/latest-news/fda-approves-voraxaze-to-treat-patients-with-toxic-methotrexate-levels/feed/ 0 FDA to protect important class of antimicrobial drugs for treating human illness http://www.remsadvisor.com/latest-news/fda-to-protect-important-class-of-antimicrobial-drugs-for-treating-human-illness/ http://www.remsadvisor.com/latest-news/fda-to-protect-important-class-of-antimicrobial-drugs-for-treating-human-illness/#comments Wed, 04 Jan 2012 20:06:20 +0000 admin http://www.remsadvisor.com/latest-news/fda-to-protect-important-class-of-antimicrobial-drugs-for-treating-human-illness/ Agency issues order prohibiting certain uses in food-producing animals
 
The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.
]]> http://www.remsadvisor.com/latest-news/fda-to-protect-important-class-of-antimicrobial-drugs-for-treating-human-illness/feed/ 0 FDA approves shared system REMS for TIRF products http://www.remsadvisor.com/latest-news/fda-approves-shared-system-rems-for-tirf-products/ http://www.remsadvisor.com/latest-news/fda-approves-shared-system-rems-for-tirf-products/#comments Thu, 29 Dec 2011 20:04:27 +0000 admin http://www.remsadvisor.com/?p=1758 The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

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]]> http://www.remsadvisor.com/latest-news/fda-approves-shared-system-rems-for-tirf-products/feed/ 0 FDA expands use of HIV drug Isentress to children and adolescents http://www.remsadvisor.com/latest-news/fda-expands-use-of-hiv-drug-isentress-to-children-and-adolescents/ http://www.remsadvisor.com/latest-news/fda-expands-use-of-hiv-drug-isentress-to-children-and-adolescents/#comments Wed, 21 Dec 2011 20:02:47 +0000 admin http://www.remsadvisor.com/?p=1756 Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

The drug is part of a class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. It was first approved for use in adult patients in October 2007, under FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.

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]]> http://www.remsadvisor.com/latest-news/fda-expands-use-of-hiv-drug-isentress-to-children-and-adolescents/feed/ 0 FDA approves mechanical cardiac assist device for children with heart failure http://www.remsadvisor.com/latest-news/fda-approves-mechanical-cardiac-assist-device-for-children-with-heart-failure/ http://www.remsadvisor.com/latest-news/fda-approves-mechanical-cardiac-assist-device-for-children-with-heart-failure/#comments Fri, 16 Dec 2011 20:01:28 +0000 admin http://www.remsadvisor.com/latest-news/fda-approves-mechanical-cardiac-assist-device-for-children-with-heart-failure/  

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.

The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

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]]> http://www.remsadvisor.com/latest-news/fda-approves-mechanical-cardiac-assist-device-for-children-with-heart-failure/feed/ 0 FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies http://www.remsadvisor.com/latest-news/fda-proposes-draft-guidelines-intended-to-improve-the-representation-of-women-in-medical-device-clinical-studies/ http://www.remsadvisor.com/latest-news/fda-proposes-draft-guidelines-intended-to-improve-the-representation-of-women-in-medical-device-clinical-studies/#comments Fri, 16 Dec 2011 19:59:58 +0000 admin http://www.remsadvisor.com/?p=1753 Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

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]]> http://www.remsadvisor.com/latest-news/fda-proposes-draft-guidelines-intended-to-improve-the-representation-of-women-in-medical-device-clinical-studies/feed/ 0