CDER New: 9/16/2020

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

September 15, 2020

• Drug Trial Snapshot: GAVRETO
• CDER Warning Letters 2020 (updated)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Timolol Maleate Ophthalmic Solution (Updated - Currently in Shortage)
  • Tobramycin Lyophilized Powder for Injection (Updated - Currently in Shortage)
• Guidance for Industry:
  • Geriatric Information in Human Prescription Drug and Biological Product Labeling
  • Eosinophilic Esophagitis: Developing Drugs for Treatment

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 14, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Apixaban ANDA #209898	Apixaban	Tablet; Oral	ORIG-1	Indoco		Approved
Dextrose 5% and Sodium Chloride 0.9% ANDA #211211	Dextrose; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved

September 13, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Botox BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5317	Allergan	Labeling	Approved
Botox Cosmetic BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5317	Allergan	Labeling	Approved