What's New on the FDA Drugs Site
April 25, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Public Notification: “Sex Plus” Contains Hidden Drug Ingredient
- Public Notification: “Zoom-Zooma-Zoom” Contains Hidden Drug Ingredient
- Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 84KB)
New and Generic Drug Approvals
April 24, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Colyte | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Colyte With Flavor Packs | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Colyte-Flavored | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Manufacturing Change or Addition |
| Cutivate | fluticasone propionate | Lotion; Topical | Fougera Pharms | Manufacturing Change or Addition |
| Estradiol | estradiol | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
| Famvir | famciclovir | Tablet; Oral | Novartis | Labeling Revision |
| Humira | adalimumab | Syringe | Abbott | Manufacturing Change or Addition |
| Humira | adalimumab | Vial | Abbott | Manufacturing Change or Addition |
| Jalyn | dutasteride; tamsulosin hydrochloride | Capsule; Oral | Glaxosmithkline | Labeling Revision |
| Prezista | darunavir ethanolate | Tablet; Oral | Janssen Prods | Efficacy Supplement with Clinical Data to Support |
| Prezista | darunavir ethanolate | Suspension; Oral | Janssen Prods | Efficacy Supplement with Clinical Data to Support |
| Primella 1/35 | norethindrone; ethinyl estradiol | Tablet; Oral | Lupin Ltd | Approval |
| Primella 7/7/7 | norethindrone; ethinyl estradiol | Tablet; Oral | Lupin Ltd | Approval |
| Promethazine Hydrochloride and Codeine Phosphate | codeine phosphate; promethazine hydrochloride | Syrup; Oral | Amneal Pharms | Approval |
| Vivelle-Dot | estradiol | Film, Extended Release; Transdermal | Novartis | Manufacturing Change or Addition |
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