| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Savella® | milnacipran | Cypress | fibromyalgia | 1/14/2009 | 28:16.04.16 - Selective Serotonin- and Norepinephrine-reuptake Inhibitors; 28:40 - Fibromyalgia Agents | ||
| Dexilant® | dexlansoprazole | Takeda | erosive esophagitis; gastroesophageal reflux disease | 1/30/2009 | 56:28.36 - Proton-pump Inhibitors | ||
| Uloric® | febuxostat | Takeda | hyperuricemia in patients with gout | 2/13/2009 | 92:16 - Antigout Agents | ||
| Afinitor® | everolimus | Novartis | advanced renal cell carcinoma | 3/30/2009 | 10:00 - Antineoplastic Agents | ||
| Coartem® | artemether, lumefantrine | Novartis | malaria caused by Plasmodium falciparum | 4/7/2009 | 8:30.08 - Antimalarials | ||
| Ulesfia® | benzyl alcohol | Shionogi | head lice | 4/9/2009 | 84:04.12 - Scabicides and Pediculicides | ||
| Simponi® | golimumab | Centocor | rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis | 4/24/2009 | 92:20 - Biologic Response Modifiers; 92:36 - Disease-modifying Antirheumatic Agents | ||
| Dysport® | abobotulinumtoxinA | Ipsen | cervical dystonia; glabellar lines | 4/29/2009 | 12:20.92 - Skeletal Muscle Relaxants, Misc; 92:92 - Other Miscellaneous Therapeutic Agents | ||
| Aralast®, Prolastin®, Zemaira® | α1-Proteinase inhibitor (human) | - | congenital deficiency of α1-PI with evident emphysema | 4/30/2009 | from 44:00 - Enzymes to 48:92 - Respiratory Agents, Miscellaneous | ||
| Fanapt® | iloperidone | Novartis | schizophrenia | 5/6/2009 | 28:16.08.04 - Atypical Antipsychotics | ||
| Samsca® | tolvaptan | Otsuka | hyponatremia | 5/19/2009 | 40:28.92 - Diuretics, Misc | ||
| Besivance® | besifloxacin | Bausch & Lomb | bacterial conjunctivitis | 5/28/2009 | 52:04.04 - Antibacterials | ||
| Welchol® | colesevelam | Daiichi Sankyo | hyperlipidemia; glycemic control in type 2 diabetes | 6/1/2009 | 24:06.04 - Bile Acid Sequestrants; 68:20.92 - Miscellaneous Antidiabetic Agents | ||
| Ilaris® | canakinumab | Novartis | cryopyrin-associated periodic syndromes | 6/17/2009 | 92:92 - Other Misc Therapeutic Agents | ||
| Cambia® | diclofenac potassium oral solution | Assertio | acute migraines | 6/17/2009 | 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents; 28:32.92 - Antimigraine Agents, Misc | ||
| Feraheme® | ferumoxytol | Amag | iron deficiency anemia | 6/30/2009 | 20:04.04 - Iron Preparations | ||
| NutreStore® | L-glutamine | Emmaus | short bowel syndrome | 6/30/2009 | from 40:20 - Caloric Agents to 56:92 - GI Drugs, Misc | ||
| Multaq® | dronedarone | Sanofi Aventis | prevent atrial fibrillation or flutter | 7/1/2009 | 24:04.04.20 - Class III Antiarrhythmics | ||
| Effient® | prasugrel | Eli Lilly | reduce the risk of blood clots in patients who undergo angioplasty | 7/10/2009 | 20:12.18 - Platelet-Aggregation Inhibitors | ||
| Onglyza® | saxagliptin | Bristol Myers Squibb | type 2 diabetes mellitus | 7/31/2009 | 68:20.05 - Dipeptidyl Peptidase-4 Inhibitors (DPP-4) | ||
| Livalo® | pitavastatin | Kowa | hypercholesterolemia and combined dyslipidemia | 8/3/2009 | 24:0608 - HMG-CoA Reductaste Inhibitors | ||
| Saphris® | asenapine | Organon | schizophrenia and bipolar disorder | 8/13/2009 | 28:16.08.04 - Atypical Antipsychotics | ||
| Extavia® | interferon beta-1b | Novartis | multiple sclerosis | 8/14/2009 | 92:20 - Biologic Response Modifiers | ||
| Sabril® | vigabatrin | Lundbeck | refractory complex partial seizures | 8/21/2009 | 28:12.92 - Anticonvulsants, Misc | ||
| Cimzia® | certolizumab | UCB | Crohn's disease | 9/1/2009 | 56:92 - Miscellaneous GI Drugs; 92:36 - Disease-modifying Antirheumatic Agents | ||
| Intuniv® | guanfacine | Shire | attention deficit hyperactivity disorder | 9/2/2009 | 28:92 - CNS Agents, Misc | ||
| Bepreve® | bepotastine | Ista | allergic conjunctivitis | 9/8/2009 | 52:02 - Antiallergic Agents | ||
| Vibativ® | telavancin | Astellas | bacterial skin infections | 9/11/2009 | 8:12.28.16 - Glycopeptides | ||
| Folotyn® | pralatrexate | Allos | relapsed or refractory peripheral T-cell lymphoma | 9/24/2009 | 10:00 - Antineoplastic Agents | ||
| Stelara® | ustekinumab | Centocor Ortho Biotech | plaque psoriasis | 9/25/2009 | 84:92 - Skin and Mucous Membrane Agents, Misc | ||
| Berinert® | C1 esterase inhibitor | CSL Behring | treatment of hereditary angioedema (HAE) | 10/9/2009 | 92:32 - Complement Inhibitors | ||
| Votrient® | pazopanib | Glaxo Smith Kline | advanced renal cell carcinoma | 10/19/2009 | 10:00 - Antineoplastic Agents | ||
| Arzerra® | ofatumumab | Glaxo Grp | chronic lymphocytic leukemia | 10/26/2009 | 10:00 - Antineoplastic Agents | ||
| Istodax® | romidepsin | Celgene | cutaneous T-cell lymphoma | 11/5/2009 | 10:00 - Antineoplastic Agents | ||
| Kalbitor® | ecallantide | Dyax | hereditary angioedema | 11/27/2009 | 92:92 - Other Misc Therapeutic Agents |
| AHFS Class | Retired | Change Description |
|---|---|---|
| 20:12.14 - Platelet-reducing Agents | - | New classification |
| 92:04 - Alcohol Deterrents | - | New classification |
| 92:08 - 5-α-Reductase Inhibitors | - | New classification |
| 92:12 - Antidotes | - | New classification |
| 92:16 - Antigout Agents | - | New classification |
| 92:20 - Biologic Response Modifiers | - | New classification |
| 92:24 - Bone Resorption Inhibitors | - | New classification |
| 92:28 - Cariostatic Agents | - | New classification |
| 92:32 - Complement Inhibitors | - | New classification |
| 92:36 - Disease-modifying Antirheumatic Agents | - | New classification |
| 92:40 - Gonadotropin-releasing Hormone Antagonists | - | New classification |
| 92:44 - Immunosuppressive Agents | - | New classification |
| 92:56 - Protective Agents | - | New classification |
| 92:92 - Other Miscellaneous Therapeutic Agents | - | New classification |