What's New on the FDA Drugs Site
June 17, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Public Notification: Gold Vigra Contains Hidden Drug Ingredient
- Public Notification: Miraculous Evil Root Contains Hidden Drug Ingredient
- Public Notification: Sport Burner Contains Hidden Drug Ingredient
- Public Notification: Toxin Discharged Tea Contains Hidden Drug Ingredient
- Public Notification: Sliming Diet Contains Hidden Drug Ingredient
- Guidance for Industry
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 135KB)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF - 176KB)
- Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
June 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bio-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Labeling Revision |
| Daptomycin | daptomycin | Injectable;Injection | Hospira Inc | Tentative Approval |
| Noxafil | posaconazole | Suspension;Oral | Schering | Manufacturing Change or Addition |
| Nutropin Aq | somatropin recombinant | Injectable;Injection | Genentech | Labeling Revision |
| Nutropin Aq Pen | somatropin recombinant | Injectable;Injection | Genentech | Labeling Revision |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Supplement |
| Saizen | somatropin recombinant | Injectable;Injection | Emd Serono | Labeling Revision |
| Serostim | somatropin recombinant | Injectable;Injection | Emd Serono | Labeling Revision |
| Serostim Lq | somatropin recombinant | Injectable;Subcutaneous | Emd Serono | Labeling Revision |
| Tev-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Labeling Revision |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Supplement |
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