What's New on the FDA Drugs Site
May 30, 2013
- FDA Drug Safety Communication: FDA Drug Safety Communication: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies
- Clinical Development Programs for Opioid Conversion; Public Workshop; Request for Comments, July 29, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry: Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF - 177KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- MedWatch Safety Alert: Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
- MedWatch Safety Alert: Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
- National Drug Code Directory
- Spanish Drug Safety Communication: Sulfato de magnesio - FDA recomienda que no se use el sulfato de magnesio por periodos prolongados para detener partos prematuros debido a cambios en los huesos de los bebés expuestos
New and Generic Drug Approvals
May 29, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aggrenox | aspirin; dipyridamole | Capsule, Extended Release; Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Axiron | testosterone | Solution, Metered; Transdermal | Eli Lilly and Co | Manufacturing Change or Addition |
| Bss Plus | calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate | Solution; Irrigation | Alcon | Manufacturing Change or Addition |
| Dextroamphetamine Sulfate | dextroamphetamine sulfate | Solution; Oral | Tris Pharma Inc | Approval |
| Exjade | deferasirox | Tablet, For Suspension; Oral | Novartis | Labeling Revision |
| Infuvite Adult | alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k | Injectable; Iv (Infusion) | Sandoz | Manufacturing Change or Addition |
| Lexapro | escitalopram oxalate | Tablet; Oral | Forest Labs | Manufacturing Change or Addition |
| Magnesium Sulfate | magnesium sulfate | Injectable; Injection | Fresenius Kabi Usa | Labeling Revision |
| Magnesium Sulfate In Plastic Container | magnesium sulfate | Injectable; Injection | Hospira | Labeling Revision |
| Mekinist | trametinib | Tablet; Oral | Glaxosmithkline Llc | Approval |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release; Oral | Endo Pharms | Manufacturing Change or Addition |
| Oxytrol | oxybutynin | Film, Extended Release; Transdermal | Watson Labs (Utah) | Manufacturing Change or Addition |
| Pravachol | pravastatin sodium | Tablet; Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Prostin E2 | dinoprostone | Suppository; Vaginal | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Stivarga | regorafenib | Tablet; Oral | Bayer Hlthcare | Labeling Revision |
| Tafinlar | dabrafenib | Capsule; Oral | Glaxosmithkline | Approval |
| Teflaro | ceftaroline fosamil | Powder; Iv (Infusion) | Cerexa | Labeling Revision |
| Timentin In Plastic Container | clavulanate potassium; ticarcillin disodium | Injectable; Injection | Glaxosmithkline | Manufacturing Change or Addition |
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