What's New on the FDA Drugs Site
February 14, 2013
- Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing, February 25, 2013, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503B, Silver Spring, MD. Meeting information
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Public Workshop, Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop, March 22, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
February 13, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Argatroban | argatroban | Injectable; Injection | Hikma Pharm Co Ltd | Manufacturing Change or Addition |
| Calan | verapamil hydrochloride | Tablet; Oral | Gd Searle Llc | Manufacturing Change or Addition |
| Claritin-D 24 Hour | loratadine; pseudoephedrine sulfate | Tablet, Extended Release; Oral | Schering Plough | Manufacturing Change or Addition |
| Dextrose 2.5% In Half-Strength Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | B Braun | Labeling Revision |
| Dextrose 4% In Modified Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | B Braun | Labeling Revision |
| Dextrose 5% In Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable; Injection | B Braun | Labeling Revision |
| Gralise | gabapentin | Tablet; Oral | Depomed Inc | Manufacturing Change or Addition |
| Orfadin | nitisinone | Capsule; Oral | Rare Dis | Labeling Revision |
| Oxytocin | oxytocin | Injectable; Injection | Hikma Farmaceutica | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Synthon Pharms | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Sandoz | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Torrent Pharms Ltd | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Accord Hlthcare | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Pioglitazone Hydrochloride | pioglitazone hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
| Pioglitazone Hydrochloride and Metformin Hydrochloride | metformin hydrochloride; pioglitazone hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Pioglitazone Hydrochloride and Metformin Hydrochloride | metformin hydrochloride; pioglitazone hydrochloride | Tablet; Oral | Torrent Pharms Ltd | Approval |
| Saizen | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Signifor | pasireotide diaspartate | Solution; Subcutaneous | Novartis | Labeling Revision |
| Victrelis | boceprevir | Capsule; Oral | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support |
| Xylocaine | lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine W/ Epinephrine | epinephrine; lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
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