What's New on the FDA Drugs Site
February 25, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA alerts health care providers of recall of anemia drug Omontys
- FDA approves Stivarga (regorafenib) for advanced gastrointestinal stromal tumors
- Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers(R2)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
February 22, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | buprenorphine hydrochloride; naloxone hydrochloride | Tablet; Sublingual | Actavis Elizabeth | Approval |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | buprenorphine hydrochloride; naloxone hydrochloride | Tablet; Sublingual | Amneal Pharms | Approval |
| Carnitor | levocarnitine | Solution; Oral | Sigma Tau | Manufacturing Change or Addition |
| Carnitor | levocarnitine | Tablet; Oral | Sigma Tau | Manufacturing Change or Addition |
| Copaxone | glatiramer acetate | For Solution; Subcutaneous | Teva | Manufacturing Change or Addition |
| Copaxone | glatiramer acetate | Injectable; Subcutaneous | Teva | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Doxepin Hydrochloride | doxepin hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc | Tentative Approval |
| Irbesartan; Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Irbesartan; Hydrochlorothiazide | hydrochlorothiazide; irbesartan | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Kadcyla | ado-trastuzumab emtansine | Vial; Single-Use | Genentech | Approval |
| Levonorgestrel | levonorgestrel | Tablet; Oral | Novel Labs Inc | Approval |
| Myambutol | ethambutol hydrochloride | Tablet; Oral | Sti Pharma Llc | Manufacturing Change or Addition |
| Ondansetron | ondansetron | Injectable; Injection | Claris Lifesciences | Approval |
| Ondansetron | ondansetron | Injectable; Injection | Claris Lifesciences | Approval |
| Potassium Chloride | potassium chloride | Capsule, Extended Release; Oral | Amneal Pharms | Approval |
| Prezista | darunavir ethanolate | Tablet; Oral | Janssen Prods | Labeling Revision |
| Prezista | darunavir ethanolate | Suspension; Oral | Janssen Prods | Labeling Revision |
| Qualaquin | quinine sulfate | Capsule; Oral | Mutual Pharm Co Inc | Labeling Revision |
| Ranitidine Hydrochloride | ranitidine hydrochloride | Injectable; Injection | Zydus Pharms Usa Inc | Approval |
| Valproic Acid | valproic acid | Capsule; Oral | Sun Pharm Inds Ltd | Approval |
| Zioptan | tafluprost | Solution/Drops; Ophthalmic | Merck Sharp Dohme | Labeling Revision |
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