What's New on the FDA Drugs Site
October 22, 2013
- Manual of Policies and Procedures (MAPP) 4510.2 Rev.2 CDER Clearance of FDA-Related Articles, Speeches, and Other Publications (PDF - 188KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
October 21, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actemra | tocilizumab | Injectable; Injection | Genentech | Labeling Revision |
| Darunavir Ethanolate | darunavir ethanolate | Tablet; Oral | Mylan Pharms Inc | Tentative Approval |
| Exjade | deferasirox | Tablet, For Suspension;Oral | Novartis | Labeling Revision |
| Pennsaid | diclofenac sodium | Solution;Topical | Mallinckrodt | Labeling Revision |
| Raloxifene Hydrochloride | raloxifene hydrochloride | Tablet; Oral | Watson Labs Inc | Tentative Approval |
| Solodyn | minocycline hydrochloride | Tablet, Extended Release;Oral | Medicis | Labeling Revision |
| Zyprexa | olanzapine | Tablet;Oral | Lilly | Manufacturing Change or Addition |
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