What's New on the FDA Drugs Site
February 11, 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)
- Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2012
New and Generic Drug Approvals
February 8, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arthrotec | diclofenac sodium; misoprostol | Tablet, Delayed Release; Oral | Gd Searle Llc | Manufacturing Change or Addition |
| Carbidopa and Levodopa | carbidopa; levodopa | Tablet, Extended Release; Oral | Accord Hlthcare | Approval |
| Differin | adapalene | Cream; Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Foradil | formoterol fumarate | Powder; Inhalation | Novartis | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff Pen | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45% | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.45% | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Moxifloxacin Hydrochloride | moxifloxacin hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Myfortic | mycophenolic acid | Tablet, Delayed Release; Oral | Novartis | Manufacturing Change or Addition |
| Ovidrel | choriogonadotropin alfa | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Ovidrel | choriogonadotropin alfa | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Pomalyst | pomalidomide | Capsule; Oral | Celgene | Approval |
| Revlimid | lenalidomide | Capsule; Oral | Celgene | Efficacy Supplement with Clinical Data to Support |
| Revlimid | lenalidomide | Capsule; Oral | Celgene | Labeling Revision |
| Risperdal | risperidone | Tablet; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Thalomid | thalidomide | Capsule; Oral | Celgene | Efficacy Supplement with Clinical Data to Support |
| Trileptal | oxcarbazepine | Tablet; Oral | Novartis | Labeling Revision |
| Trileptal | oxcarbazepine | Suspension; Oral | Novartis | Labeling Revision |
| Vimpat | lacosamide | Tablet; Oral | Ucb Inc | Labeling Revision |
| Vimpat | lacosamide | Solution; Intravenous | Ucb Inc | Labeling Revision |
| Vimpat | lacosamide | Solution; Oral | Ucb Inc | Labeling Revision |
| Viramune | nevirapine | Suspension; Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
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