CDER New: 2/10/2021

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 9, 2021 Drugs@FDA Data Files (updated) FDA D.I.S.C.O. Burst Edition: FDA Approvals of Xalkori for patients 1-21 years with ALK-positive ALCL and Enhertu for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma FDA Drug Shortages Azacitidine for Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Pantoprazole Sodium for Injection (Updated - 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. February 9, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Droxia NDA #016295 Hydroxyurea Capsule; Oral SUPPL-54 Bristol Myers Squibb Labeling Approved Hydrea NDA #016295 Hydroxyurea Capsule; Oral SUPPL-54 Bristol Myers Squibb Labeling Approved Botox BLA #103000 Onabotulinumtoxina Vial; Single-Use SUPPL-5318 Allergan Efficacy Approved Botox Cosmetic BLA #103000 Onabotulinumtoxina Vial; Single-Use SUPPL-5318 Allergan Efficacy Approved Libtayo BLA #761097 Cemiplimab-Rwlc Injectable; Intravenous SUPPL-8 Regeneron Pharmaceuticals Efficacy Approved Libtayo BLA #761097 Cemiplimab-Rwlc Injectable; Intravenous SUPPL-9 Regeneron Pharmaceuticals Efficacy Approved Zirabev BLA #761099 Bevacizumab-Bvzr Injectable; Injection SUPPL-4 Pfizer Inc Efficacy Approved Zirabev BLA #761099 Bevacizumab-Bvzr Injectable; Injection SUPPL-6 Pfizer Inc Labeling Approved February 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Diazepam ANDA #070311 Diazepam Injectable; Injection SUPPL-20 West-Ward Pharms Int Labeling Approved Flurazepam Hydrochloride ANDA #070345 Flurazepam Hydrochloride Capsule; Oral SUPPL-23 Mylan Pharms Inc Labeling Approved Diazepam ANDA #072370 Diazepam Injectable; Injection SUPPL-7 Watson Labs Inc Labeling Approved Buprenorphine Hydrochloride ANDA #078633 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-20 Hikma Labeling Approved Irbesartan ANDA #090201 Irbesartan Tablet; Oral SUPPL-6 Hikma Labeling Approved Buprenorphine Hydrochloride ANDA #090819 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-18 Actavis Elizabeth Labeling Approved Buprenorphine Hydrochloride ANDA #090819 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-18 Actavis Elizabeth Labeling Approved Oxymorphone Hydrochloride ANDA #090964 Oxymorphone Hydrochloride Tablet; Oral SUPPL-5 Hikma Labeling Approved Oxymorphone Hydrochloride ANDA #090964 Oxymorphone Hydrochloride Tablet; Oral SUPPL-7 Hikma Labeling Approved Oxymorphone Hydrochloride ANDA #090964 Oxymorphone Hydrochloride Tablet; Oral SUPPL-8 Hikma Labeling Approved Methadone Hydrochloride ANDA #207537 Methadone Hydrochloride Solution; Oral SUPPL-1 Specgx Llc Labeling Approved Methadone Hydrochloride ANDA #207537 Methadone Hydrochloride Solution; Oral SUPPL-1 Specgx Llc Labeling Approved Oxymorphone Hydrochloride ANDA #210175 Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Ascent Pharms Inc Labeling Approved Oxymorphone Hydrochloride ANDA #210175 Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Ascent Pharms Inc Labeling Approved Tavaborole ANDA #212168 Tavaborole Solution; Topical ORIG-1 Lupin Ltd   Approved Clobetasol Propionate ANDA #213139 Clobetasol Propionate Solution; Topical ORIG-1 Prinston Inc   Approved Darzalex Faspro BLA #761145 Daratumumab;Hyaluronidase-Fihj Injectable; Injection SUPPL-8 Janssen Biotech 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