What's New on the FDA Drugs Site
April 5, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF – 183KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- Medication Guides (updated)
- MedWatch Safety Alert: BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 4, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acitretin | acitretin | Capsule; Oral | Barr Labs Inc | Approval |
| Acitretin | acitretin | Capsule; Oral | Teva Pharms Usa | Approval |
| Aricept | donepezil hydrochloride | Tablet; Oral | Eisai Inc | Labeling Revision |
| Aricept Odt | donepezil hydrochloride | Tablet, Orally Disintegrating; Oral | Eisai Inc | Labeling Revision |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container | clindamycin phosphate | Injectable; Injection | Akorn Inc | Approval |
| Cromolyn Sodium | cromolyn sodium | Solution; Oral | Micro Labs Ltd India | Approval |
| Dificid | fidaxomicin | Tablet; Oral | Optimer Pharms | Labeling Revision |
| 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 |
| Isentress | raltegravir potassium | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Isentress | raltegravir potassium | Tablet, Chewable; Oral | Merck Sharp Dohme | Labeling Revision |
| Omnitrope | somatropin recombinant | Injectable; Injection | Sandoz | Manufacturing Change or Addition |
| Vantas | histrelin acetate | Implant; Subcutaneous | Endo Pharm | Labeling Revision |
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