CDER New: 2/15/2022

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 February 14, 2022 FDA 正调查淋巴瘤药物Ukoniq (厄布利塞)可能增加的死亡风险 (Chinese language translation of Drug Safety Communication: FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) FDA Drug Shortages Dextrose 5% Injection (New - Currently in Shortage) Office of Generic Drugs 2021 Annual Report 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 14, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Gazyva BLA #125486 Obinutuzumab Injectable; Injection SUPPL-29 Genentech Efficacy Approved February 11, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Hibiclens NDA #017768 Chlorhexidine Gluconate Solution; Topical SUPPL-56 Molnlycke Hlth Labeling Approved Esbriet NDA #022535 Pirfenidone Capsule; Oral SUPPL-15 Genentech Inc Labeling Approved Procysbi NDA #203389 Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-27 Horizon Labeling Approved Procysbi NDA #203389 Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-27 Horizon Labeling Approved Esbriet NDA #208780 Pirfenidone Tablet; Oral SUPPL-5 Genentech Inc Labeling Approved Braftovi NDA #210496 Encorafenib Capsule; Oral SUPPL-13 Array Biopharma Inc Labeling Approved Procysbi NDA #213491 Cysteamine Bitartrate Granule, Delayed Release; Oral SUPPL-2 Horizon Pharma Usa Labeling Approved Procysbi NDA #213491 Cysteamine Bitartrate Granule, Delayed Release; Oral SUPPL-2 Horizon Pharma Usa Labeling Approved Praxbind BLA #761025 Idarucizumab Injectable; Injection SUPPL-13 Boehringer Ingelheim 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