What's New on the FDA Drugs Site
August 4, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB)
- Manual of Policies and Procedures (MAPP)
- National Drug Code Directory
New and Generic Drug Approvals
August 1, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Differin | adapalene | Cream;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Epiduo | adapalene; benzoyl peroxide | Gel;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Halaven | eribulin mesylate | Solution;Intravenous | Eisai Inc | Labeling Revision |
| Inlyta | axitinib | Tablet;Oral | Pfizer | Labeling Revision |
| Jardiance | empagliflozin | Tablet;Oral | Boehringer Ingelheim | Approval |
| Keppra Xr | levetiracetam | Tablet, Extended Release;Oral | Ucb Inc | Efficacy Supplement with Clinical Data to Support |
| Loestrin Fe 1/20 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-28 | Warner Chilcott | Manufacturing Change or Addition |
| Lumizyme | alglucosidase alfa | Powder; Iv (Infusion) | Genzyme | Efficacy Supplement with Clinical Data to Support |
| Metronidazole In Plastic Container | metronidazole | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Capsule;Oral | Lannett Holdings Inc | Approval |
| Sterile Water For Injection In Plastic Container | sterile water for injection | Liquid;N/A | Hospira | Manufacturing Change or Addition |
| Tyvaso | treprostinil | Solution;Inhalation | United Therap | Labeling Revision |
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