What's New on the FDA Drugs Site
August 8, 2014
- CDER Key Official List (PDF - 125KB) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Dihydroergotamine Mesylate Injection (Currently in Shortage)
- Methylprednisolone Sodium Succinate Injection (Resolved)
- Peritoneal Dialysis Solutions (Currently in Shortage)
- Ranitidine Hydrochloride (Zantac) Injection (Currently in Shortage)
- Sulfamethoxazole and Trimethoprim (Bactrim) Oral Suspension (Currently in Shortage)
- Tenecteplase (TNKase) Injection (Currently in Shortage)
- MedWatch Safety Alert - Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter
- National Drug Code Directory
- Pediatric Exclusivity Statistics (updated)
New and Generic Drug Approvals
August 7, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Angiomax | bivalirudin | Injectable;Intravenous | Medicines Co | Manufacturing Change or Addition |
| Axert | almotriptan malate | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Delflex W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Humira | adalimumab | Syringe | Abbvie Inc | Manufacturing Change or Addition |
| Humira | adalimumab | Vial | Abbvie Inc | Manufacturing Change or Addition |
| Norpramin | desipramine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Optimark | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Optimark | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Optimark In Plastic Container | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
