CDER New: 8/9/2021

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 August 6, 2021 FDA Drug Shortages Busulfan Injection (New - Discontinuation) Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials 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. August 5, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Droxia NDA #016295 Hydroxyurea Capsule; Oral SUPPL-55 Bristol Myers Squibb Labeling Approved Hydrea NDA #016295 Hydroxyurea Capsule; Oral SUPPL-55 Bristol Myers Squibb Labeling Approved Omnipaque 12 NDA #018956 Iohexol Solution; Oral SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 140 NDA #018956 Iohexol Injectable; Injection SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 180 NDA #018956 Iohexol Solution; Injection, Oral, Rectal SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 210 NDA #018956 Iohexol Injectable; Injection SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 240 NDA #018956 Iohexol Solution; Injection, Oral, Rectal SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 300 NDA #018956 Iohexol Solution; Injection, Oral, Rectal SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 350 NDA #018956 Iohexol Solution; Injection, Oral SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 70 NDA #018956 Iohexol Solution; Urethral SUPPL-112 Ge Healthcare Labeling Approved Omnipaque 9 NDA #018956 Iohexol Solution; Oral SUPPL-112 Ge Healthcare Labeling Approved Thalomid NDA #020785 Thalidomide Capsule; Oral SUPPL-70 Celgene REMS Approved Revlimid NDA #021880 Lenalidomide Capsule; Oral SUPPL-63 Celgene REMS Approved Qutenza NDA #022395 Capsaicin Patch; Topical SUPPL-20 Averitas Labeling Approved Zuplenz NDA #022524 Ondansetron Film; Oral SUPPL-7 Aquestive Labeling Approved Carbaglu NDA #022562 Carglumic Acid Tablet, For Suspension; Oral SUPPL-13 Recordati Rare Labeling Approved Lenalidomide ANDA #201452 Lenalidomide Capsule; Oral SUPPL-1 Natco Pharma Ltd REMS Approved Pomalyst NDA #204026 Pomalidomide Capsule; Oral SUPPL-29 Celgene REMS Approved Acyclovir ANDA #212444 Acyclovir Ointment; Topical SUPPL-1 Macleods Pharms Ltd Manufacturing (CMC) Approved August 4, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Morphine Sulfate ANDA #203158 Morphine Sulfate Capsule, Extended Release; Oral ORIG-1 Nortec Dev Assoc   Approved Injectafer NDA #203565 Ferric Carboxymaltose Solution; Intravenous SUPPL-17 Am Regent Labeling Approved Docetaxel NDA #205934 Docetaxel Injectable; Injection SUPPL-5 Shilpa Labeling Approved Docetaxel NDA #205934 Docetaxel Injectable; Injection SUPPL-5 Shilpa Labeling Approved Corlanor NDA #206143 Ivabradine Hydrochloride Tablet; Oral SUPPL-8 Amgen Inc Labeling Approved Corlanor NDA #206143 Ivabradine Hydrochloride Tablet; Oral SUPPL-8 Amgen Inc Labeling Approved Corlanor NDA #209964 Ivabradine Solution; Oral SUPPL-2 Amgen Inc Labeling Approved Corlanor NDA #209964 Ivabradine Solution; Oral SUPPL-2 Amgen Inc Labeling Approved Clomipramine Hydrochloride ANDA #211822 Clomipramine Hydrochloride Capsule; Oral ORIG-1 Alembic Pharms Ltd   Approved Ramelteon ANDA #213186 Ramelteon Tablet; Oral SUPPL-2 Granules Labeling Approved Ramelteon ANDA #213186 Ramelteon Tablet; Oral SUPPL-2 Granules Labeling Approved Dexamethasone Sodium Phosphate ANDA #215654 Dexamethasone Sodium Phosphate Injectable; Injection ORIG-1 Gland Pharma Ltd   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