What's New on the FDA Drugs Site
July 23, 2015
- CDER Data Standards Program (updated)
- FDA Drug Safety Podcast: FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide)
New and Generic Drug Approvals
July 22, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Boniva | ibandronate sodium | Injectable;Intravenous | Roche | Manufacturing Change or Addition |
| Korlym | mifepristone | Tablet;Oral | Corcept Therap | Manufacturing Change or Addition |
| Lotensin | benazepril hydrochloride | Tablet;Oral | Us Pharms Holdings I | Labeling Revision |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | ethinyl estradiol; norethindrone acetate | Capsule;Oral | Warner Chilcott | Manufacturing Change or Addition |
| Rivastigmine | rivastigmine | System; Transdermal | Alvogen Inc | Tentative Approval |
| Zykadia | ceritinib | Capsule;Oral | Novartis Pharms Corp | Labeling Revision |
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Friday, July 24, 2015
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