What's New on the FDA Drugs Site
February 6, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA's Efforts to Address the Misuse and Abuse of Opioid Medications
- National Drug Code Directory (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
February 5, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Benztropine Mesylate | benztropine mesylate | Injectable; Injection | Navinta Llc | Approval |
| Calcium Acetate | calcium acetate | Tablet; Oral | Invagen Pharms | Approval |
| Definity | perflutren | Injectable; Intravenous | Lantheus Medcl | Manufacturing Change or Addition |
| Mefenamic Acid | mefenamic acid | Capsule; Oral | Cypress Pharm | Approval |
| Tricor | fenofibrate | Tablet; Oral | Abbvie | 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 |
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