CDER New: 1/20/2022

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 January 19, 2022 FDA Drug Shortages Dacarbazine Injection (Updated - Currently in Shortage) Imipenem and Cilastatin for Injection (New - 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. January 19, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Alinia NDA #021497 Nitazoxanide Tablet; Oral SUPPL-18 Romark Labeling Approved Alinia NDA #021498 Nitazoxanide For Suspension; Oral SUPPL-19 Romark Labeling Approved Veklury NDA #214787 Remdesivir Powder; Intravenous SUPPL-9 Gilead Sciences Inc Labeling Approved Veklury NDA #214787 Remdesivir Solution; Intravenous SUPPL-9 Gilead Sciences Inc Labeling Approved January 18, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Linezolid In Sodium Chloride 0.9% In Plastic Container NDA #206473 Linezolid Solution; Intravenous SUPPL-5 Hospira Inc Labeling Approved Exondys 51 NDA #206488 Eteplirsen Solution; Intravenous SUPPL-27 Sarepta Theraps Inc Labeling Approved Exondys 51 NDA #206488 Eteplirsen Solution; Intravenous SUPPL-28 Sarepta Theraps Inc Labeling Approved Exondys 51 NDA #206488 Eteplirsen Solution; Intravenous SUPPL-29 Sarepta Theraps Inc Labeling Approved Livtencity NDA #215596 Maribavir Tablet; Oral SUPPL-1 Takeda Pharms Usa Labeling Approved Clindamycin Phosphate ANDA #215607 Clindamycin Phosphate Lotion; Topical ORIG-1 Encube   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