What's New on the FDA Drugs Site
June 3, 2013
- CDERLearn (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry: M2: eCTD Specification Questions & Answers and Change Requests Companion Document
- National Drug Code Directory
- Small Business Education Series
New and Generic Drug Approvals
May 31, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bloxiverz | neostigmine methylsulfate | Injectable; Injection | Eclat Pharma | Approval |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Rebetol | ribavirin | Capsule; Oral | Merck Sharp Dohme | Labeling Revision |
| Rebetol | ribavirin | Solution; Oral | Schering | Labeling Revision |
| Restasis | cyclosporine | Emulsion; Ophthalmic | Allergan | Manufacturing Change or Addition |
| Veregen | sinecatechins | Ointment; Topical | Medigene Ag | Manufacturing Change or Addition |
| Vibativ | telavancin hydrochloride | Powder; Iv (Infusion) | Theravance Inc | Manufacturing Change or Addition |
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