What's New on the FDA Drugs Site
May 29, 2013
- Current Drug Shortages Index (updated)
- Drugs@FDA Data Files (updated)
- FDA Press Release: FDA approves two drugs, companion diagnostic test for advanced skin cancer
- FDA Press Release: FDA announces import of injectable nutrition drugs
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
New and Generic Drug Approvals
May 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clopidogrel Bisulfate | clopidogrel bisulfate | Tablet; Oral | Actavis Totowa | Approval |
| Gilenya | fingolimod | Capsule; Oral | Novartis | Efficacy Supplement with Clinical Data to Support |
| Hydrocodone Bitartrate and Ibuprofen | hydrocodone bitartrate; ibuprofen | Tablet; Oral | Sun Pharm Inds Inc | Approval |
| Isentress | raltegravir potassium | Tablet, Chewable; Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Luvox | fluvoxamine maleate | Tablet; Oral | Ani Pharms | Manufacturing Change or Addition |
| Metoprolol Tartrate | metoprolol tartrate | Tablet; Oral | Alembic Pharms Ltd | Approval |
| Sirolimus | sirolimus | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
| Sucraid | sacrosidase | Solution; Oral | Qol Medcl | Manufacturing Change or Addition |
| Telmisartan; Amlodipine | telmisartan; amlodipine | Tablet; Oral | Lupin Ltd | Tentative Approval |
| Viracept | nelfinavir mesylate | Powder; Oral | Agouron | Labeling Revision |
| Viracept | nelfinavir mesylate | Tablet; Oral | Agouron | Labeling Revision |
| Viracept | nelfinavir mesylate | Tablet; Oral | Agouron | Labeling Revision |
| Voriconazole | voriconazole | For Suspension; Oral | Mylan Pharms Inc | Approval |
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