What's New on the FDA Drugs Site
August 23, 2012
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry:
New and Generic Drug Approvals
August 22, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Nedocromil Sodium | nedocromil sodium | Solution; Ophthalmic | Akorn Inc | Approval |
Ortho Evra | ethinyl estradiol; norelgestromin | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |