What's New on the FDA Drugs Site
November 23, 2016
- Drug Review Package
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Elvitegravir (VITEKTA) Tablets (New - Discontinuation)
- Telavancin (Vibativ) Injection (New - Discontinuation)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB)
- Office of Translational Sciences (updated)
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
- Product-Specific Recommendations for Generic Drug Development: Cyclobenzaprine HCl (PDF - 26KB)
- Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance
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