CDER New: 5/18/2021

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 May 17, 2021 Statement on Leronlimab (new) COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry FDA Drug Shortages Pantoprazole Sodium for Injection (Updated - Currently in Shortage) Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry 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. May 17, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Curosurf BLA #020744 Poractant Alfa Suspension; Intratracheal SUPPL-43 Chiesi Usa Inc Labeling Approved Curosurf BLA #020744 Poractant Alfa Suspension; Intratracheal SUPPL-43 Chiesi Usa Inc Labeling Approved May 16, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Zinacef NDA #050558 Cefuroxime Sodium Injectable; Injection SUPPL-76 Teligent Labeling Approved Zinacef NDA #050558 Cefuroxime Sodium Injectable; Intramuscular, Intravenous SUPPL-76 Teligent Labeling Approved Zinacef In Plastic Container NDA #050643 Cefuroxime Sodium Injectable; Injection SUPPL-27 Teligent Labeling Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA