What's New on the FDA Drugs Site
August 5, 2014
- FDA Drug Shortages: New and Updated
- Cidofovir Injection (Currently in Shortage)
- Doxorubicin (Adriamycin) Lyophilized Powder (Currently in Shortage)
- Methylphenidate Hydrochloride ER Capsules/Tablets (Resolved)
- Rifampin for Injection (Currently in Shortage)
- Sulfamethoxazole and Trimethoprim (Bactrim) Oral Suspension (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
- Guidance for Industry: Upper Facial Lines: Developing Botulinum Toxin Drug Products (PDF - 240KB)
- Notice of Public Meeting; Request for Comments: Advancing the Use of Biomarkers and Pharmacogenomics. September 5, 2014. Washington Plaza Hotel, Washington, DC.
New and Generic Drug Approvals
August 4, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ketorolac Tromethamine | ketorolac tromethamine | Injectable;Injection | Agila Speclts | Approval |
| Myfortic | mycophenolic acid | Tablet, Delayed Release;Oral | Novartis | Manufacturing Change or Addition |
| Sirturo | bedaquiline fumarate | Tablet;Oral | Janssen Therap | Manufacturing Change or Addition |
August 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Miralax | polyethylene glycol 3350 | For Solution;Oral | Schering Plough | Manufacturing Change or Addition |
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