What's New on the FDA Drugs Site
December 8, 2014
- FDA Drug Shortages: Updated
- Disopyramide Phosphate (Norpace) Capsules (Currently in Shortage)
- Draft Guidance: DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers (PDF - 94KB)
- Draft Guidance: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF - 375KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
December 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify Maintena Kit | aripiprazole | For Suspension, Extended Release;Intramuscular | Otsuka Pharm Co Ltd | Efficacy Supplement with Clinical Data to Support |
| Adriamycin Pfs | doxorubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Benzaclin | benzoyl peroxide; clindamycin phosphate | Gel;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Benzamycin | benzoyl peroxide; erythromycin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Cardiogen-82 | rubidium chloride rb-82 | Injectable;Injection | Bracco | Manufacturing Change or Addition |
| Exparel | bupivacaine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Labeling Revision |
| Heparin Sodium | heparin sodium | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Heparin Sodium Preservative Free | heparin sodium | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Klaron | sulfacetamide sodium | Lotion;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Minastrin 24 Fe | ethinyl estradiol; norethindrone acetate | Tablet, Chewable;Oral | Warner Chilcott Llc | Labeling Revision |
| Noritate | metronidazole | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Efficacy Supplement with Clinical Data to Support |
| Tricor | fenofibrate | Tablet;Oral | Abbott | Labeling Revision |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Efficacy Supplement with Clinical Data to Support |
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