What's New on the FDA Drugs Site
January 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Current Drug Shortages Index (updated)
- FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market
- Medical, Statistical, Clinical Pharmacology and Written Requests of Pediatric Reviews FDAAA/BPCA (updated)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
January 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Brevital Sodium | methohexital sodium | Injectable;Injection | Jhp Pharms | Labeling Revision |
| Carbaglu | carglumic acid | Tablet;Oral | Orphan Europe | Manufacturing Change or Addition |
| Cellcept | mycophenolate mofetil | Capsule;Oral | Roche Palo | Manufacturing Change or Addition |
| Cellcept | mycophenolate mofetil | Tablet;Oral | Roche Palo | Manufacturing Change or Addition |
| Decitabine | decitabine | Injectable; Injection | Sun Pharma Global | Approval |
| Docetaxel | docetaxel | Injectable;Injection | Hospira Inc | Manufacturing Change or Addition |
| Ethiodol | ethiodized oil | Oil;Intralymphatic, Intrauterine | Guerbet | Manufacturing Change or Addition |
| Etodolac | etodolac | Tablet, Extended Release;Oral | Zydus Pharms Usa Inc | Approval |
| Infuvite Adult | alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k | Injectable;Iv (Infusion) | Sandoz | Manufacturing Change or Addition |
| Ondansetron | ondansetron | Tablet; Oral | Ipca Labs Ltd | Approval |
| Onglyza | saxagliptin hydrochloride | Tablet;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Pertzye | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Digestive Care Inc | Manufacturing Change or Addition |
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