What's New on the FDA Drugs Site
August 11, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 75KB)
- National Drug Code Directory
- Priority Therapeutic Areas for Development (updated)
- Warning Letters 2015 (updated)
New and Generic Drug Approvals
August 10, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atropen | atropine | Injectable;Injection | Meridian Medcl Techn | Manufacturing Change or Addition |
| Campral | acamprosate calcium | Tablet, Delayed Release;Oral | Forest Labs | Manufacturing Change or Addition |
| Cerezyme | imiglucerase | Injectable;Injection | Genzyme | Manufacturing Change or Addition |
| Doribax | doripenem | Injectable;Iv (Infusion) | Shionogi Inc | Labeling Revision |
| Firazyr | icatibant acetate | Injectable;Subcutaneous | Shire Orphan Therap | Labeling Revision |
| Monistat 7 | miconazole nitrate | Cream;Vaginal | Medtech Products | Manufacturing Change or Addition |
| Myrbetriq | mirabegron | Tablet, Extended Release;Oral | Apgdi | Labeling Revision |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Zubsolv | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Orexo Ab | Efficacy Supplement with Clinical Data to Support |
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Wednesday, August 12, 2015
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