| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Actemra® | tocilizumab | Genentech | rheumatoid arthritis | 1/20/2010 | 92:36 - Disease-modifying Antirheumatic Agents | ||
| Ampyra® | dalfampridine | Acorda | multiple sclerosis | 1/22/2010 | 92:92 - Other Misc Therapeutic Agents | ||
| Victoza® | liraglutide | Novo Nordisk | type 2 diabetes | 1/25/2010 | 68:20.06 - Incretin Mimetics | ||
| Xiaflex® | collagenase clostridium histolyticum | Auxilium | adult Dupuytren's contracture patients with a palpable cord | 2/2/2010 | 44:00 - Enzymes | ||
| VPRIV® | velaglucerase alfa | Shire | type 1 Gaucher disease | 2/26/2010 | 44:00 - Enzymes | ||
| Carbaglu® | carglumic acid | Orphan Europe | N-acetylglutamate synthase (NAGS) deficiency | 3/18/2010 | 40:10 - Ammonia Detoxicants | ||
| Asclera® | polidocanol | BioForm Medical | small vericose veins | 3/30/2010 | 24:16 - Sclerosing Agents | ||
| Iprivask® | desirudin | Canyon | prophylaxis of deep vein thrombosis in patients undergoing hip replacement surgery | 3/30/2010 (launched) | 20:12.04.12 - Direct Thrombin Inhibitors | ||
| TachoSil® | fibrin sealant patch (fibrinogen; thrombin) | Omrix | hemostasis during surgery | 4/05/2010 | 84:92 - Skin and Mucous Membrane Agents, Misc | ||
| Solesta® | dextranomer; hyaluronate | Oceana | fecal incontinence | 4/09/2010 | 94:24 - Gastroenterology and Urology Devices | ||
| Provenge® | sipuleucel-T | Dendreon | treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer | 4/29/2010 | 26:00 - Cellular Therapy | ||
| Natazia® | estradiol valerate/dienogest | Bayer | contraceptive | 5/6/2010 | 68:12 - Contraceptive | ||
| Prolia®, XGEVA® | denosumab | Amgen | treatment of postmenopausal women with osteoporosis at high risk for fracture | 6/1/2010 | 92:24 - Bone Resorption Inhibitors | ||
| Jalyn® | dutasteride/tamsulosin | GSK | benign prostatic hyperplasia | 6/14/2010 | 92:08 - 5-α-Reductase Inhibitors; 12:16.04.12 - Selective α1 Adrenergic Blocking Agents | ||
| Jevtana® | cabazitaxel | Sanofi Aventis | hormone-refractory metastatic prostate cancer | 6/17/2010 | 10:00 - Antineoplastic Agents | ||
| Glassia®® | alpha-1-proteinase inhibitor (human) | Kamada | congenital alpha-1 antitrypsin deficiency with clinically evident emphysema | 7/1/2010 | 48:92 - Respiratory Tract Agents, Misc | ||
| Vaprisol®; Samsca® | conivaptan; tolvaptan | Astellas; Otsuka | euvolemic and hypervolemic hyponatremia | 7/1/2010 | from 40:28.92 to new class 40:28.28 - Vasopressin Antagonists | ||
| Lymphazurin® | isosulfan blue | Mylan | contrast agent for the delineation of lymphatic vessels | 7/20/2010 | 36:46 - Lymphatic System | ||
| Lastacaft® | alcaftadine | Vistakon | allergic conjunctivitis | 7/28/2010 | 52:02 - Antiallergic Agents (EENT) | ||
| Xeomin® | incobotulinumtoxinA | Merz | cervical dystonia, blepharospasm | 7/30/2010 | 92:92 - Other Misc Therapeutic Agents | ||
| Ella® | ulipristal | Watson | emergency contraceptive | 8/13/2010 | 68:12 - Contraceptives | ||
| Krystexxa® | pegloticase | Savient | chronic gout | 9/14/2010 | 92:16 - Antigout Agents | ||
| Gilenya® | fingolimod | Novartis | multiple sclerosis | 9/21/2010 | 92:20 - Biologic Response Modifiers | ||
| Introvale® | ethinyl estradiol; levonorgestrel | Labs Leon | birth control | 9/27/2010 | 68:12 - Contraceptives | ||
| Aridol® | mannitol | Pharmaxis | bronchial challenge test | 10/5/2010 | 36:70 - Respiratory Function (new class) | ||
| Pradaxa® | dabigatran | Boehringer Ingelheim | preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation | 10/19/2010 | 20:12.04.12 - Direct Thrombin Inhibitors | ||
| Latuda® | lurasidone | Sunovion | schizophrenia | 10/28/2010 | 28:16.08.04 - Atypical Antipsychotics | ||
| Teflaro® | ceftaroline | Cerexa | acute skin and skin structure infections and community-acquired pneumonia caused by susceptible strains, including MRSA | 10/29/2010 | 8:12.06.20 - Fifth Generation Cephalosporins (new class) | ||
| Nuedexta® | dextromethorphan/ quinidine |
Avanir | pseudobulbar affect (PBA) | 10/29/2010 | 28:92 - Central Nervous System Agents, Misc | ||
| Egrifta® | tesamorelin | Thera-technologies | lipodystrophy in HIV patients | 11/10/2010 | 68:30.04 - Somatotropin Agonists | ||
| Halaven® | eribulin | EISAI | metastatic breast cancer | 11/15/2010 | 10:00 - Antineoplastic Agents |
| AHFS Class | Retired | Change Description |
|---|---|---|
| 12:16.04 - α-Adrenergic Blocking Agents | - | New classification |
| 12:16.04.04 - Non-selective α-Adrenergic Blocking Agents | - | New classification |
| 12:16.04.08 - Non-selective α1-Adrenergic Blocking Agents | - | New classification |
| 12:16.04.12 - Selective α1-Adrenergic Blocking Agents | - | New classification |
| 12:16.08 - β-Adrenergic Blocking Agents | - | New classification |
| 12:16.08.04 - Non-selective β-Adrenergic Blocking Agents | - | New classification |
| 12:16.08.08 - Selective β-Adrenergic Blocking Agents | - | New classification |
| 28:40 - Fibromyalgia Agents | - | New classification |