What's New on the FDA Drugs Site
June 23, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Sivextro (tedizolid phosphate) to treat skin infections
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
June 20, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets;Oral | Abbvie | Labeling Revision |
| Dronabinol | dronabinol | Capsule;Oral | Akorn Inc | Approval |
| Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Indiclor | indium in-111 chloride | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Isovue-200 | iopamidol | Injectable;Injection | Bracco | Labeling Revision |
| Isovue-250 | iopamidol | Injectable;Injection | Bracco | Labeling Revision |
| Isovue-300 | iopamidol | Injectable;Injection | Bracco | Labeling Revision |
| Isovue-370 | iopamidol | Injectable;Injection | Bracco | Labeling Revision |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Solution;Oral | Lehigh Valley | Manufacturing Change or Addition |
| Retisert | fluocinolone acetonide | Implant;Intravitreal | Bausch and Lomb | Manufacturing Change or Addition |
| Sivextro | tedixolid phosphate | Tablet;Oral | Cubist Pharms | Approval |
| Sivextro | tedizolid phosphate | Injectable;Injection | Cubist Pharms | Approval |
| Tribenzor | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Manufacturing Change or Addition |
| Trokendi Xr | topiramate | Capsule, Extended Release;Oral | Supernus Pharms | Manufacturing Change or Addition |
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