What's New on the FDA Drugs Site
June 5, 2013
- Current Drug Shortages Index (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
June 4, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Metadate Cd | methylphenidate hydrochloride | Capsule, Extended Release; Oral | Ucb Inc | Labeling Revision |
| Mozobil | plerixafor | Solution; Subcutaneous | Genzyme | Labeling Revision |
| Pregabalin | pregabalin | Solution; Oral | Lupin Ltd | Tentative Approval |
| Zetia | ezetimibe | Tablet; Oral | Msd Intl Gmbh | Manufacturing Change or Addition |
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