December 19, 2019
- Compounding Quality Center of Excellence
- Drug Approval Packages:
- REBLOZYL (luspatercept-aamt) (PDF)
- FETROJA (cefiderocol) (PDF)
- Selenious Acid Injection (PDF)
- Levothyroxine Sodium Injection (PDF)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Buspirone HCl Tablets (Updated - Currently in Shortage)
- Promethazine Hydrochloride Injection, Solution (New - Discontinuation)
- Trifluridine Ophthalmic Solution (Updated - Currently in Shortage)
- Valsartan Tablets (Updated - Currently in Shortage)
- FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
- National Drug Code Directory (updated)
- NDC Unfinished Drugs Excluded Database File (updated)
- NDC Database Excluded Packages and Products (updated)
- SBIA Chronicles: Improving Regulatory Communication via the CDER NextGen Portal (December 19, 2019 Issue)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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