CDER New: 9/25/2020

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 24, 2020

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• FDA Drug Safety Communication: FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

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 24, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-20	Organon Usa Inc	Labeling	Approved
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-20	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Revlimid NDA #021880	Lenalidomide	Capsule; Oral	SUPPL-54	Celgene	REMS	Approved
Benlysta BLA #125370	Belimumab	Injectable; Injection	SUPPL-71	Human Genome Sciences Inc.	Efficacy	Approved

September 23, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Travasol 10% In Plastic Container NDA #018931	Amino Acids	Injectable; Injection	SUPPL-55	Baxter Hlthcare	Labeling	Approved
Travasol 5.5% In Plastic Container NDA #018931	Amino Acids	Injectable; Injection	SUPPL-55	Baxter Hlthcare	Labeling	Approved
Travasol 8.5% In Plastic Container NDA #018931	Amino Acids	Injectable; Injection	SUPPL-55	Baxter Hlthcare	Labeling	Approved
Prosol 20% Sulfite Free In Plastic Container NDA #020849	Amino Acids	Injectable; Injection	SUPPL-25	Baxter Hlthcare	Labeling	Approved
Lumify NDA #208144	Brimonidine Tartrate	Solution/Drops; Ophthalmic	SUPPL-11	Bausch and Lomb Inc	Labeling	Approved