What's New on the FDA Drugs Site
February 5, 2013
- Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Response Letter Regarding Approval of Ampligen for ME/CFS
- Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS): Questions and Answers
- Medication Guides (updated)
- National Drug Code Directory (updated)
- Warning Letters 2012 (updated)
New and Generic Drug Approvals
February 4, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Advil Pm | diphenhydramine hydrochloride; ibuprofen | Capsule; Oral | Pfizer | Manufacturing Change or Addition |
| Doxorubicin Hydrochloride | doxorubicin hydrochloride | Injectable, Liposomal; Injection | Sun Pharma Global | Approval |
| Eovist | gadoxetate disodium | Solution; Intravenous | Bayer Hlthcare | Manufacturing Change or Addition |
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