What's New on the FDA Drugs Site
April 3, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory (updated)
- Public Notificaton: “Ninja Mojo” Contains Hidden Drug Ingredient
- Public Notification: “Love Rider” Contains Hidden Drug Ingredient
- Public Notification: “AFFIRM XL” Contains Hidden Drug Ingredient
- Current Drug Shortages Index (updated)
- Paragraph IV Patent Certifications (updated)
- Warning Letters 2013 (updated)
New and Generic Drug Approvals
April 2, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azithromycin | azithromycin | Injectable; Injection | Sun Pharm Inds Ltd | Approval |
| Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Emtriva | emtricitabine | Capsule; Oral | Gilead | Labeling Revision |
| Emtriva | emtricitabine | Solution; Oral | Gilead | Labeling Revision |
| Lac-Hydrin | ammonium lactate | Lotion; Topical | Ranbaxy | Manufacturing Change or Addition |
| Orfadin | nitisinone | Capsule; Oral | Rare Dis | Manufacturing Change or Addition |
| Supprelin La | histrelin acetate | Implant; Subcutaneous | Endo Pharm | Labeling Revision |
| Verdeso | desonide | Aerosol, Foam; Topical | Stiefel Labs Inc | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Powder; Oral | Gilead Sciences Inc | Labeling Revision |
| Xenical | orlistat | Capsule; Oral | Hoffmann La Roche | Manufacturing Change or Addition |
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