What's New on the FDA Drugs Site
April 9, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (BPCA/FDASIA)
- National Drug Code Directory (updated)
- Pediatric Statistics:
- Pediatric Exclusivity Statistics (updated)
- Spectrum of Diseases/Conditions (updated)
- Written Requests Issued (updated)
- Small Business Education Series
New and Generic Drug Approvals
April 8, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cytovene | ganciclovir sodium | Injectable; Injection | Roche Palo | Approval |
| Endometrin | progesterone | Insert; Vaginal | Ferring | Manufacturing Change or Addition |
| Nithiodote | sodium nitrite; sodium thiosulfate | Solution, Solution; Intravenous, Intravenous | Hope Pharms | Approval |
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