What's New on the FDA Drugs Site
June 7, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP): 7600.8R1 CDER Informatics Governance Process (PDF - 308KB) (Revision)
- National Drug Code Directory
- Pediatric Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
New and Generic Drug Approvals
June 6, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alphagan | brimonidine tartrate | Solution/Drops; Ophthalmic | Allergan | Manufacturing Change or Addition |
| Banzel | rufinamide | Tablet; Oral | Eisai Inc | Manufacturing Change or Addition |
| Daytrana | methylphenidate | Film, Extended Release; Transdermal | Noven Pharms Inc | Labeling Revision |
| Dificid | fidaxomicin | Tablet; Oral | Optimer Pharms | Manufacturing Change or Addition |
| Potiga | ezogabine | Tablet; Oral | Glaxosmithkline | Labeling Revision |
| Sotalol Hydrochloride | sotalol hydrochloride | Solution; Intravenous | Academic Pharms | Manufacturing Change or Addition |
| Sporanox | itraconazole | Solution; Oral | Janssen Pharms | Manufacturing Change or Addition |
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