What's New on the FDA Drugs Site
October 24, 2013
- Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
- Medication Guides (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 23, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adriamycin Pfs | doxorubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Atripla | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead | Labeling Revision |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Kineret | anakinra | Vial; Subcutaneous | Biovitrum Ab | Labeling Revision |
| Lamisil | terbinafine hydrochloride | Tablet;Oral | Novartis | Labeling Revision |
| Lamisil | terbinafine hydrochloride | Granule;Oral | Novartis | Labeling Revision |
| Lovenox | enoxaparin sodium | Injectable;Intravenous, Subcutaneous | Sanofi Aventis Us | Labeling Revision |
| Lovenox (Preservative Free) | enoxaparin sodium | Injectable;Subcutaneous | Sanofi Aventis Us | Labeling Revision |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Suboxone | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Reckitt Benckiser | Manufacturing Change or Addition |
| Truvada | emtricitabine; tenofovir disoproxil fumarate | Tablet;Oral | Gilead | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Powder;Oral | Gilead Sciences Inc | Labeling Revision |
| Zyrtec-D 12 Hour | cetirizine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Mcneil | Manufacturing Change or Addition |
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