CDER New January 31, 2019

• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride (QUILLICHEW ER) Extended-Release Chewable Tablets (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride (QUILLIVANT XR) for Extended-Release Oral Suspension (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Trifluoperazine Hydrochloride Tablets (Updated - Currently in Shortage)
• First Generic Drug Approvals (updated)
• Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry (PDF - 87 KB)