What's New on the FDA Drugs Site
December 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA approves weight-management drug Saxenda (liraglutide [rDNA origin] injection)
- Guidance for Industry: DSCSA Implementation: Product Tracing Requirements — Compliance Policy (PDF - 56KB)
- MedWatch Safety Alert: Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
- National Drug Code Directory
December 23, 2014
- Public Notification: Slim-K contains hidden drug ingredients
- FDA Drug Shortages: New and Updated
- Newly Added Generic Name or Active Ingredient
- Quazepam (Doral) Tablets (Currently in Shortage)
- Updated
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Newly Added Generic Name or Active Ingredient
- Bioequivalence Recommendations for Specific Products: Methylphenidate HCl (PDF - 38KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
December 22, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cordarone | amiodarone hydrochloride | Tablet;Oral | Wyeth Pharms Inc | Labeling Revision |
| Dextrose 10% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 20% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 30% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 40% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 5% and Potassium Chloride 0.075% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 5% and Potassium Chloride 0.15% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 5% and Potassium Chloride 0.224% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 5% and Potassium Chloride 0.3% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 5% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 50% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 50% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 60% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 60% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 70% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Dextrose 70% In Plastic Container | dextrose | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Extavia | interferon beta-1b | Injectable; Subcutaneous | Novartis Pharms | Labeling Revision |
| Opdivo | nivolumab | Injectable;Injection | Bristol Myers Squibb | Approval |
| Plasma-Lyte 56 and Dextrose 5% In Plastic Container | dextrose; magnesium acetate tetrahydrate; potassium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Potassium Chloride | potassium chloride | Solution; Oral | Pharma-Med Inc | Approval |
| Remodulin | treprostinil | Injectable;Iv (Infusion), Subcutaneous | United Therap | Labeling Revision |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Sodium Chloride 3% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Sodium Chloride 5% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Somatuline Depot | lanreotide acetate | Injectable;Subcutaneous | Ipsen Pharma | Labeling Revision |
| Tykerb | lapatinib ditosylate | Tablet;Oral | Smithkline Beecham | Labeling Revision |
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