| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Subsys® | fentanyl | Insys | breakthrough cancer pain in opioid-tolerant patients | 1/4/2012 | 28:08.08 - Opiate Agonists | 3 | 202788 |
| Voraxaze® | glucarpidase | BTG Int'l | methotrexate toxicity | 1/17/2012 | 92:12 - Antidotes; 44:00 - Enzymes | 1 | |
| Myorisan® | isotretinoin | Douglas | severe nodular acne; psoriasis | 1/19/2012 | 84:92 - Skin and Mucous Membrane Agents, Misc | ||
| Alyacen 1/35®; Alyacen 7/7/7® | ethinyl estradiol; norethindrone | Glenmark | birth control | 1/19/2012 | 68:12 - Contraceptives | ||
| Zetonna® | ciclesonide | Nycomed | allergic rhinitis | 1/20/2012 | 52:08.08 - Corticosteroids | 3 | |
| Picato® | ingenol mebutate | Leo Pharma | actinic keratosis | 1/23/2012 | 84:92 - Skin and Mucous Membrane Agents, Misc | 1 | |
| Bydureon® | exenatide | Amylin | Type 2 diabetes | 1/27/2012 | 68:20.06 - Incretin Mimetics | 3 | |
| Inlyta® | axitinib | Pfizer | advanced renal cell carcinoma | 1/27/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Jentadueto® | linagliptin, metformin | Boehringer Ingelheim | type 2 diabetes mellitus | 1/30/2012 | 68:20.05 - Dipeptidyl Peptidase-4 (DPP-4) Inhibitors; 68:20.04 - Biguanides | 4 | |
| Erivedge® | vismodegib | Genentech | metastatic or locally advanced basal cell carcinoma | 1/30/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Kalydeco® | ivacaftor | Vertex | cystic fibrosis | 1/31/2012 | 48:92 - Respiratory Agents, Misc | 1 | |
| Giazo® | balsalazide | Salix | active ulcerative colitis | 2/3/2012 | 56:36 - Anti-inflammatory Agents | 3 | |
| Sklice® | ivermectin | Sanofi Pasteur | head lice | 2/7/2012 | 84:04.12 - Scabicides and Pediculicides | 3 | |
| Zioptan® | tafluprost | Merck Sharp Dohme | reduce intraocular pressure associated with open-angle glaucoma or ocular hypertension | 2/10/2012 | 52:40.28 - Prostaglandin Analogs | 1 | |
| Korlym® | mifepristone | Corcept | type 2 diabetes mellitus with endogenous Cushing's syndrome | 2/17/2012 | 68:20.92 - Antidiabetic Agents, Misc | 5 | |
| Ultresa, Viokace® | pancrelipase | Aptalis | pancreatic insufficiency | 3/1/2012 | 56:16 - Digestants | 7 | |
| Surfaxin® | lucinactant | Discovery Labs | prevention of respiratory distress syndrome in premature infants | 3/6/2012 | 48:36 - Pulmonary Surfactants | 1 | |
| Binosto® | alendronate | Effrx Pharm | osteoporosis | 3/12/2012 | 92:24 - Bone Resorption Inhibitors | 3 | |
| Qnasl® | beclomethasone | Teva | seasonal and perennial allergic rhinitis | 3/23/2012 | 52:08.08 - Corticosteroids | 3 | |
| Suprenza® | phentermine | Citius | weight loss | 3/27/2012 | 28:20.92 - Anorexigenic Agents and Respiratory and Cerebral Stimulants, Misc | 3 | |
| Omontys® | peginesatide | Affymax | anemia due to chronic kidney disease in adult patients on dialysis | 3/27/2012 | 20:16 - Hematopoietic Agents | 1 | |
| Amyvid® | florbetapir F18 | Avid | detection of amyloid proteins associated with Alzheimer's disease | 4/6/2012 | 78:00 - Radioactive Agents | 1 | |
| Stendra® | avanafil | Vivus | erectile dysfunction | 4/27/2012 | 24:12.12 - Phosphodiesterase Type 5 Inhibitors | 1 | |
| Elelyso® | taliglucerase alfa | Protalix | type 1 Gaucher disease | 5/1/2012 | 44:00 - Enzymes | 1 | |
| Dymista® Nasal Spray | azelastine/ fluticasone | Meda | seasonal allergic rhinitis | 5/1/2012 | 52:02 - Antiallergic Agents; 52:08.08 - Corticosteroids (also cross-referenced under 48:04.08 & 48:10.08.04) | 4 | |
| Fabior® Foam | tazarotene | Stiefel | acne vulgaris | 5/11/2012 | 84:92 - Skin and Mucous Membrane Agents, Misc | 3 | |
| Pertzye® | pancrelipase | Digestive Care | pancreatic insufficiency | 5/17/2012 | 56:16 - Digestants | 7 | |
| Perjeta® | pertuzumab | Genentech | HER2-positive metastatic breast cancer | 6/8/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Trokendi® XR | topiramate | Supernus | epilepsy | 6/25/2012 | 28:12.92 - Anticonvulsants, Misc | 3 | |
| Belviq® | lorcaserin | Arena | weight loss | 6/27/2012 | 28:20.92 - Anorexigenic Agents and Respiratory and Cerebral Stimulants, Misc | 1 | |
| Myrbetriq® | mirabegron | Astellas | overactive bladder | 6/28/2012 | 86:12 - Genitourinary Smooth Muscle Relaxants | 1 | |
| Ximino® | minocycline | Ranbaxy | inflammatory lesions of non-nodular moderate to severe acne vulgaris | 7/11/2012 | 84:92 - Skin and Mucous Membrane Agents, Misc | 3 | |
| Prepopik® | sodium picosulfate; magnesium oxide; citric acid | Ferring | bowel evacuation prior to colonoscopy | 7/16/2012 | 56:12 - Cathartics and Laxatives | 1 | |
| Qsymia® | phentermine; topiramate | Vivus | weight loss | 7/17/2012 | 28:20.92 - Anorexigenic Agents and Respiratory and Cerebral Stimulants, Misc | 4 | |
| Kyprolis® | carfilzomib | Onyx | multiple myeloma | 7/20/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Tudorza® | aclidinium | Forest | COPD | 7/23/2012 | 12:08.08 - Antimuscarinics / Antispasmodics | 1 | |
| Rayos® | prednisone | Horizon | anti-inflammatory, immuno-suppression | 7/26/2012 | 68:04 - Adrenals | 1 | |
| Vascepa® | icosapent ethyl (omega-3 fatty acid) | Amarin | hyper-triglyceridemia | 7/26/2012 | 24:06.92 - Antilipemic Agents, Misc | 1 | |
| Zaltrap® | ziv-aflibercept | Sanofi | metastatic colorectal cancer | 8/3/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Marqibo® | vincristine | Talon | (Ph-) acute lymphoblastic leukemia (ALL) | 8/9/2012 | 10:00 - Antineoplastic Agents | 5 | |
| Stribild® | elvitegravir / cobicistat / emtricitabine / tenofovir | Gilead | HIV infection | 8/27/2012 | 8:18.08.12 - Integrase Inhibitors; 92:92 - Other Miscellaneous Therapeutic Agents; 8:18.08.20 - Nucleoside and Nucleotide Reverse Transcriptase Inhibitors | 1 | |
| Granix® (formerly Neutroval®) | tbo-filgrastim | Sicor | severe neutropenia | 8/29/2012 | 20:16 - Hematopoietic Agents | 1 | |
| Linzess® | linaclotide | Forest | irritable bowel syndrome w/ constipation | 8/30/2012 | 56:92 - GI Drugs, Miscellaneous | 1 | |
| Xtandi® | enzalutamide | Medivation | metastatic prostate cancer | 8/31/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Bosulif® | bosutinib | Pfizer | (Ph+) chronic myeloid leukemia | 9/4/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Aubagio® | teriflunomide | Sanofi | multiple sclerosis | 9/12/2012 | 92:20 - Biologic Response Modifiers (changed from 92:92 on 9/27/12) | 1 | |
| Stivarga® | regorafenib | Bayer | metastatic colorectal cancer (CRC) | 9/27/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Cystaran® | cysteamine | Sigma Tau | corneal cystine crystal accumulation in patients with cystinosis | 10/2/2012 | 52:92 - EENT Drugs, Misc | 3 | |
| Bethkis® | tobramycin | Chiesi | management of cystic fibrosis patients with Pseudomonas aeruginosa infection | 10/12/2012 | 8:12.02 - Aminoglycosides | 3 | |
| Jetrea® | ocriplasmin | ThromboGenics | vitreomacular adhesion | 10/18/2012 | 52:92 - EENT Drugs, Misc | 1 | |
| Oxtellar XR® | oxcarbazepine extended-release | Supernus | adjunctive therapy in partial seizures | 10/19/2012 | 28:12.92 - Anticonvulsants, Misc | 3 | |
| Fycompa® | perampanel | Eisai | partial onset seizures | 10/22/2012 | 28:12.92 - Anticonvulsants, Misc | 1 | |
| Synribo® | omacetaxine | Ivax | chronic myeloid leukemia | 10/26/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Xeljanz® | tofacitinib | Pfizer | rheumatoid arthritis | 11/6/2012 | 92:36 - Disease-modifying Antirheumatic Drugs | 1 | |
| Cometriq® | cabozantinib | Exelixis | thyroid cancer | 11/29/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Rescula® | unoprostone | Sucampo | open-angle glaucoma; ocular hypertension | 12/7/2012 | 52:40.28 - Prostaglandin Analogs | 5 | |
| raxibacumab | Human Genome Sciences / GSK | inhalational anthrax | 12/14/2012 | 8:92 - Anti-infectives, Misc | 1 | ||
| Signifor® | pasireotide | Novartis | Cushing's disease | 12/14/2012 | 92:92 - Other Misc Therapeutic Agents | 1 | |
| Iclusig® | ponatinib | Ariad | CML and Ph+ ALL | 12/14/2012 | 10:00 - Antineoplastic Agents | 1 | |
| Bivigam® | immune globulin intravenous (human) | Biotest | primary humoral immunodeficiency (PI) | 12/19/2012 | 80:04 - Serums | ||
| Gattex® | teduglutide | NPS | short bowel syndrome | 12/21/2012 | 56:92 - GI Drugs, Misc | 1 | |
| Juxtapid® | lomitapide | Aegerion | homozygous familial hyper-cholesterolemia (HoFH) | 12/21/2012 | 24:06.92 - Antilipemic Agents, Misc | 1S | |
| Eliquis® | apixaban | BMS | reduce stroke and embolism assoc with nonvalvular atrial fibrillation | 12/28/2012 | 20:12.04.14 - Direct Factor Xa Inhibitors | 1P | |
| Sirturo® | bedaquiline | Janssen | multi-drug resistant tuberculosis (MDR-TB) | 12/28/2012 | 8:16.04 - Antituberculosis Agents | 1P | |
| Fulyzaq® | crofelemer | Salix | diarrhea assoc with antiretroviral therapy | 12/31/2012 | 56:08 - Antidiarrhea Agents | 1P |
| AHFS Class | Retired | Change Description |
|---|---|---|
| 8:18.40 |
- | New classification (HCV Protease Inhibitors) |
| 20.12.04.14 |
- | New classification (Direct Factor Xa Inhibitors) |
| 24:12.12 |
- | Classification change (Phosphodiesterase Type 5 Inhibitors) |
| 48:32 |
- | New classification (Phosphodiesterase Type 4 Inhibitors) |
| 56:28.92 |
- | New classification (Antiulcer Agents and Acid Suppressants, Misc) |