What's New on the FDA Drugs Site
April 21, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
- MedWatch Safety Alert: Cubicin (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter
- National Drug Code Directory
- Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics, May 19-20, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
- Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October – December 2013
New and Generic Drug Approvals
April 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Edarbi | azilsartan kamedoxomil | Tablet;Oral | Arbor Pharms Ireland | Labeling Revision |
| Edarbyclor | azilsartan kamedoxomil; chlorthalidone | Tablet;Oral | Arbor Pharms Ireland | Labeling Revision |
| Minivelle | estradiol | Film, Extended Release;Transdermal | Noven | Manufacturing Change or Addition |
| Morphine Sulfate | morphine sulfate | Solution;Oral | Roxane | Manufacturing Change or Addition |
| Morphine Sulfate | morphine sulfate | Tablet; Oral | Roxane | Manufacturing Change or Addition |
| Nasonex | mometasone furoate monohydrate | Spray, Metered;Nasal | Schering Plough | Manufacturing Change or Addition |
| Precedex | dexmedetomidine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Trokendi Xr | topiramate | Capsule, Extended Release;Oral | Supernus Pharms | Manufacturing Change or Addition |
| Zinecard | dexrazoxane hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
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