What's New on the FDA Drugs Site
March 8, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry: Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2013 (PDF - 48KB)
- Medication Guides (updated)
- National Drug Code Directory (updated)
- Office of Prescription Drug Promotion (OPDP) Org Listing (updated)
- Warning Letters 2013 (updated)
New and Generic Drug Approvals
March 7, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arthrotec | diclofenac sodium; misoprostol | Tablet, Delayed Release; Oral | Gd Searle Llc | Labeling Revision |
| Coly-Mycin M | colistimethate sodium | Injectable; Injection | Jhp Pharms | Labeling Revision |
| Enskyce | desogestrel; ethinyl estradiol | Tablet; Oral | Lupin Ltd | Approval |
| Lexapro | escitalopram oxalate | Tablet; Oral | Forest Labs | Manufacturing Change or Addition |
| Pregabalin | pregabalin | Capsule; Oral | Mylan Pharms Inc | Tentative Approval |
| Rapamune | sirolimus | Solution; Oral | Wyeth Pharms Inc | Labeling Revision |
| Rapamune | sirolimus | Tablet; Oral | Wyeth Pharms Inc | Labeling Revision |
| Visicol | sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate | Tablet; Oral | Salix Pharms | Labeling Revision |
| Welchol | colesevelam hydrochloride | For Suspension; Oral | Daiichi Sankyo | Manufacturing Change or Addition |
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