What's New on the FDA Drugs Site
October 17, 2013
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Safety Podcast: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins
- Investigator-Initiated Investigational New Drug (IND) Applications
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
- MedWatch Safety Alert: Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results
- MedWatch Safety Alert: Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter
- National Drug Code Directory
New and Generic Drug Approvals
October 16, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amerge | naratriptan hydrochloride | Tablet;Oral | Glaxosmithkline Llc | Labeling Revision |
| Effient | prasugrel hydrochloride | Tablet;Oral | Eli Lilly and Co | Efficacy Supplement with Clinical Data to Support |
| Eovist | gadoxetate disodium | Solution;Intravenous | Bayer Hlthcare | Labeling Revision |
| Gonal-F Rff Pen | follitropin alfa/beta | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Livalo | pitavastatin calcium | Tablet;Oral | Kowa Co | Labeling Revision |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Synera | lidocaine; tetracaine | Patch;Topical | Galen Specialty | Manufacturing Change or Addition |
| Xenical | orlistat | Capsule;Oral | Hoffmann La Roche | Labeling Revision |
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