CDER New: 9/24/2020

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 23, 2020

• FDA Drug Safety Communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)

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 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

September 22, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Eraxis NDA #021632	Anidulafungin	Powder; Intravenous	SUPPL-27	Vicuron	Efficacy	Approved
Eraxis NDA #021632	Anidulafungin	Powder; Intravenous	SUPPL-29	Vicuron	Labeling	Approved
Vancomycin Hydrochloride ANDA #202274	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-1	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202274	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-3	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202275	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-1	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202275	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-3	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202275	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-4	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202464	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-1	Emcure Pharms Ltd	Labeling	Approved
Vancomycin Hydrochloride ANDA #202464	Vancomycin Hydrochloride	Injectable; Injection	SUPPL-3	Emcure Pharms Ltd	Labeling	Approved
Linzess NDA #202811	Linaclotide	Capsule; Oral	SUPPL-16	Allergan	Efficacy	Approved
Naftifine Hydrochloride ANDA #210038	Naftifine Hydrochloride	Cream; Topical	ORIG-1	Genzum		Approved
Esomeprazole Magnesium ANDA #213158	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	ORIG-1	Cisen		Approved