CDER New: 3/1/2021

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 February 26, 2021 FDA Drug Shortages Succimer (Chemet) Capsules (New - Currently in Shortage) Public Notification: Vy & Tea contains hidden drug ingredient 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. February 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Repatha BLA #125522 Evolocumab Injectable; Injection ORIG-2 Amgen Inc Efficacy Approved Lorbrena NDA #210868 Lorlatinib Tablet; Oral SUPPL-3 Pfizer Labeling Approved Nulibry NDA #214018 Fosdenopterin Injectable; Injection ORIG-1 Origin Biosciences Inc Type 1 - New Molecular Entity Approved Pepaxto NDA #214383 Melphalan Flufenamide Injectable; Injection ORIG-1 Oncopeptides Ab Type 1 - New Molecular Entity Approved February 25, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Thalomid NDA #020785 Thalidomide Capsule; Oral SUPPL-69 Celgene Labeling Approved Olopatadine Hydrochloride ANDA #090848 Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-9 Barr Labs Inc Labeling Approved Olopatadine Hydrochloride ANDA #090848 Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-9 Barr Labs Inc Labeling Approved Amondys 45 NDA #213026 Casimersen Solution; Intravenous ORIG-1 Sarepta Theraps Inc Type 1 - New Molecular Entity Approved Ethinyl Estradiol and Norelgestromin ANDA #213950 Ethinyl Estradiol; Norelgestromin Film, Extended Release; Transdermal ORIG-1 Amneal   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