What's New on the FDA Drugs Site
October 7, 2016
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Desmopressin Acetate Injection (Updated - Resolved)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry (PDF - 103KB)
- Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF - 106KB)
New and Generic Drug Approvals
October 6, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bicnu | carmustine | Injectable;Injection | Emcure Pharms Ltd | Manufacturing Change or Addition |
| Palonosetron Hydrochloride | palonosetron hydrochloride | Injectable;Intravenous | Teva Pharms Usa | Tentative Approval |
| Pertzye | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Digestive Care Inc | Manufacturing Change or Addition |
| Retin-A | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Retin-A | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Thyrogen | thyrotropin alfa | Injectable;Injection | Genzyme | Manufacturing Change or Addition |
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Tuesday, October 11, 2016
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