CDER New: 12/02/2020

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 December 1, 2020 FDA Drug Shortages Timolol Maleate Ophthalmic Gel Forming Solution (New - Currently in Shortage) Patent Certifications and Suitability Petitions (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. December 1, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Stelara BLA #125261 Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved Stelara BLA #125261 Ustekinumab Injectable; Injection SUPPL-154 Centocor Ortho Biotech Inc Labeling Approved Hetlioz NDA #205677 Tasimelteon Capsule; Oral SUPPL-7 Vanda Pharms Inc Efficacy Approved Finacea NDA #207071 Azelaic Acid Aerosol, Foam; Topical SUPPL-2 Leo Pharma As Labeling Approved Finacea NDA #207071 Azelaic Acid Aerosol, Foam; Topical SUPPL-4 Leo Pharma As Labeling Approved Gavreto NDA #214701 Pralsetinib Capsule; Oral ORIG-1 Blueprint Medicines Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved Stelara BLA #761044 Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved Stelara BLA #761044 Ustekinumab Injectable; Injection SUPPL-6 Janssen Biotech Labeling Approved November 30, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cenestin NDA #020992 Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-38 Aspen Labeling Approved Cenestin NDA #020992 Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-39 Aspen Labeling Approved Enjuvia NDA #021443 Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-11 Aspen Labeling Approved Enjuvia NDA #021443 Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-12 Aspen Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-30 Auxilium Pharms Llc Labeling Approved Testim NDA #021454 Testosterone Gel; Transdermal SUPPL-31 Auxilium Pharms Llc Labeling Approved Amitiza NDA #021908 Lubiprostone Capsule; Oral SUPPL-18 Sucampo Pharma Llc Labeling Approved Xolair BLA #103976 Omalizumab Vial SUPPL-5235 Genentech Efficacy Approved Bupropion Hydrochloride ANDA #200216 Bupropion Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sun Pharm   Approved Adempas NDA #204819 Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved Adempas NDA #204819 Riociguat Tablet; Oral SUPPL-13 Bayer Hlthcare REMS Approved Athentia Next ANDA #206867 Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved Athentia Next ANDA #206867 Levonorgestrel Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved Sodium Chloride 0.45% In Plastic Container ANDA #208122 Sodium Chloride Injectable; Injection SUPPL-6 Fresenius Kabi Usa Manufacturing (CMC) Approved Clofarabine ANDA #209775 Clofarabine Solution; Intravenous SUPPL-1 Msn Labeling Approved Ranolazine ANDA #209953 Ranolazine Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd   Approved Dofetilde ANDA #210740 Dofetilide Capsule; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved Byfavo NDA #212295 Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved Byfavo NDA #212295 Remimazolam Besylate Powder; Intravenous SUPPL-1 Acacia Labeling Approved Penicillamine ANDA #212933 Penicillamine Tablet; Oral ORIG-1 Lupin Ltd   Approved Thyquidity NDA #214047 Levothyroxine Sodium Solution; Oral ORIG-1 Reguliance Llc Type 5 - New Formulation or New Manufacturer 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