CDER New: 2/2/2021

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 1, 2021 CDER Warning Letters 2021 (updated) 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 1, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Docefrez NDA #022534 Docetaxel Injectable; Injection SUPPL-12 Sun Pharma Global Labeling Approved Docefrez NDA #022534 Docetaxel Injectable; Injection SUPPL-12 Sun Pharma Global Labeling Approved Docetaxel NDA #022534 Docetaxel Solution; Intravenous SUPPL-12 Sun Pharma Global Labeling Approved Docetaxel NDA #022534 Docetaxel Solution; Intravenous SUPPL-12 Sun Pharma Global Labeling Approved Simponi Aria BLA #125433 Golimumab Injectable; Injection SUPPL-32 Janssen Biotech Efficacy Approved Posimir NDA #204803 Bupivacaine Injectable; Injection ORIG-1 Durect Corp Type 3 - New Dosage Form Approved Gocovri NDA #208944 Amantadine Hydrochloride Capsule, Extended Release; Oral SUPPL-4 Adamas Pharma Efficacy Approved Orilissa NDA #210450 Elagolix Sodium Tablet; Oral SUPPL-4 Abbvie Inc Efficacy Approved Orilissa NDA #210450 Elagolix Sodium Tablet; Oral SUPPL-5 Abbvie Inc Efficacy Approved Orilissa NDA #210450 Elagolix Sodium Tablet; Oral SUPPL-6 Abbvie Inc Efficacy Approved January 30, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Uptravi NDA #207947 Selexipag Tablet; Oral SUPPL-8 Actelion Pharms Ltd Efficacy 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