CDER New: 7/27/2021

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 July 26, 2021 Public Notification: Hydro Pinapple [sic] Burn contains hidden drug ingredient (new) CDER Manual of Policies and Procedures (MAPP) 5230.3 Rev.1 Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act FDA Drug Shortages Vancomycin Hydrochloride for Injection (New - Discontinuation) 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. July 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Zarxio BLA #125553 Filgrastim-Sndz Injectable; Injection SUPPL-23 Sandoz Inc Labeling Approved Zarxio BLA #125553 Filgrastim-Sndz Injectable; Injection SUPPL-23 Sandoz Inc Labeling Approved Tagrisso NDA #208065 Osimertinib Mesylate Tablet; Oral SUPPL-22 Astrazeneca Labeling Approved Zejula NDA #208447 Niraparib Tosylate Capsule; Oral SUPPL-22 Glaxosmithkline Labeling Approved Zejula NDA #208447 Niraparib Tosylate Capsule; Oral SUPPL-24 Glaxosmithkline Labeling Approved July 23, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Prezista NDA #021976 Darunavir Tablet; Oral SUPPL-62 Janssen Prods Labeling Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-107 Bristol Myers Squibb Labeling Approved Prezista NDA #202895 Darunavir Suspension; Oral SUPPL-31 Janssen Prods Labeling Approved Prezista NDA #202895 Darunavir Suspension; Oral SUPPL-31 Janssen Prods Labeling Approved Prezcobix NDA #205395 Cobicistat; Darunavir Tablet; Oral SUPPL-20 Janssen Prods Labeling Approved Prezcobix NDA #205395 Cobicistat; Darunavir Tablet; Oral SUPPL-20 Janssen Prods Labeling Approved Orbactiv NDA #206334 Oritavancin Diphosphate Powder; Intravenous SUPPL-6 Melinta Therap Labeling Approved Drizalma Sprinkle NDA #212516 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-2 Sun Pharma Global Efficacy Approved Kimyrsa NDA #214155 Oritavancin Diphosphate Powder; Intravenous SUPPL-1 Melinta Therap 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