What's New on the FDA Drugs Site
March 26, 2013
- Needleless Pre-Filled Glass Syringes (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
March 25, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet; Oral | Otsuka | Manufacturing Change or Addition |
| Coumadin | warfarin sodium | Injectable; Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| Coumadin | warfarin sodium | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Depo-Provera | medroxyprogesterone acetate | Injectable; Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Dutasteride | dutasteride | Capsule; Oral | Banner Pharmacaps | Tentative Approval |
| Gralise | gabapentin | Tablet; Oral | Depomed Inc | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Tentative Approval |
| Integrilin | eptifibatide | Injectable; Injection | Schering | Labeling Revision |
| Micro-K | potassium chloride | Capsule, Extended Release; Oral | Nesher Pharms | Manufacturing Change or Addition |
| Micro-K 10 | potassium chloride | Capsule, Extended Release; Oral | Nesher Pharms | Manufacturing Change or Addition |
March 23, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Proair Hfa | albuterol sulfate | Aerosol, Metered; Inhalation | Teva Global | Manufacturing Change or Addition |
March 22, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| 8-Mop | methoxsalen | Capsule; Oral | Valeant Pharm Intl | Manufacturing Change or Addition |
| Amyvid | florbetapir f-18 | Solution; Intravenous | Avid Radiopharms Inc | Manufacturing Change or Addition |
| Anaprox | naproxen sodium | Tablet; Oral | Hoffmann La Roche | Labeling Revision |
| Anaprox Ds | naproxen sodium | Tablet; Oral | Hoffmann La Roche | Labeling Revision |
| Carbatrol | carbamazepine | Capsule, Extended Release; Oral | Shire | Labeling Revision |
| Clozaril | clozapine | Tablet; Oral | Novartis | Labeling Revision |
| Durezol | difluprednate | Emulsion; Ophthalmic | Alcon Pharms Ltd | Efficacy Supplement with Clinical Data to Support |
| Ec-Naprosyn | naproxen | Tablet, Delayed Release; Oral | Roche Palo | Labeling Revision |
| Naprosyn | naproxen | Tablet; Oral | Roche Palo | Labeling Revision |
| Naprosyn | naproxen | Suspension; Oral | Roche Palo | Labeling Revision |
| Omnaris | ciclesonide | Spray, Metered; Nasal | Takeda Gmbh | Efficacy Supplement with Clinical Data to Support |
| Oxsoralen | methoxsalen | Lotion; Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
| Sodium Phenylbutyrate | sodium phenylbutyrate | Powder; Oral | Sigmapharm Labs Llc | Approval |
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