What's New on the FDA Drugs Site
June 26, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Safety Oversight Board Meeting, Public Summary , May 15, 2014
- FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning
- FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
- Spanish FDA Drug Safety Communications
New and Generic Drug Approvals
June 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cleocin Phosphate In Dextrose 5% In Plastic Container | clindamycin phosphate | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Famvir | famciclovir | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | Capsule;Oral | Amneal Pharms | Tentative Approval |
| Lisdexamfetamine Dimesylate | lisdexamfetamine dimesylate | Capsule;Oral | Mylan Pharms Inc | Tentative Approval |
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