What's New on the FDA Drugs Site
April 26, 2013
- ANDA Suitability Petition Reports (updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Additional News and Information
- FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration
- First-Time Generic Drug Approvals - 2013 (updated)
- Fraudulent Versions of Botox Found in the United States
- MedWatch Safety Alert: Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 25, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cefadroxil | cefadroxil/cefadroxil hemihydrate | Suspension; Oral | Aurobindo | Approval |
| Hepatolite | technetium tc-99m disofenin kit | Injectable; Injection | Pharmalucence | Manufacturing Change or Addition |
| Incivek | telaprevir | Tablet; Oral | Vertex Pharms | Labeling Revision |
| Jalyn | dutasteride; tamsulosin hydrochloride | Capsule; Oral | Glaxosmithkline | Labeling Revision |
| Nefedipine | nifedipine | Capsule; Oral | Emcure Pharms Usa | Approval |
| Oxymorphone Hydrochloride | oxymorphone hydrochloride | Tablet; Oral | Mallinckrodt Inc | Approval |
| Pradaxa | dabigatran etexilate mesylate | Capsule; Oral | Boehringer Ingelheim | Labeling Revision |
| Ranolazine | ranolazine | Tablet, Extended Release; Oral | Lupin Ltd | Tentative Approval |
| Taclonex | betamethasone dipropionate; calcipotriene hydrate | Ointment; Topical | Leo Pharma As | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
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