CDER New: 7/22/2022

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Logistics Providers Reporting July 20, 2022 CDER Conversation: CDER's Drug Quality Sampling and Testing program Draft Guidance: Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--"Dose Banding" Draft Guidance: Evaluation of Therapeutic Equivalence FDA Drug Shortages Adenosine Injection (New - Discontinuation) Alprostadil Injection (New - Discontinuation) Amikacin Sulfate Injection (New - Discontinuation) Bleomycin Injection (New - Discontinuation) Dacarbazine Injection (New - Discontinuation) Daunorubicin Hydrochloride Injection (New - Discontinuation) Desmopressin Acetate Injection (New - Discontinuation) Epoprostenol Sodium for Injection and Sterile Diluent for Epoprostenol Sodium for Injection (New - Discontinuation) Haloperidol Decanoate Injection (New - Discontinuation) Vecuronium Bromide for Injection (Updated - 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 20, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Lamotrigine ANDA #090169 Lamotrigine Tablet; Oral SUPPL-8 Glenmark Generics Labeling Approved Dextrose 5% In Plastic Container ANDA #207449 Dextrose Injectable; Injection SUPPL-19 Fresenius Kabi Usa Manufacturing (CMC) Approved Levetiracetam ANDA #212688 Levetiracetam Tablet, Extended Release; Oral SUPPL-2 Overseas Labeling Approved Levetiracetam ANDA #212688 Levetiracetam Tablet, Extended Release; Oral SUPPL-2 Overseas Labeling Approved Azilsartan Medoxomil ANDA #214489 Azilsartan Kamedoxomil Tablet; Oral ORIG-1 Lupin Ltd   Approved Nitrofurantoin (Monohydrate/Macrocrystals) ANDA #215002 Nitrofurantoin; Nitrofurantoin, Macrocrystalline Capsule; Oral ORIG-1 Alvogen   Approved Midazolam In 0.8% Sodium Chloride NDA #215868 Midazolam Solution; Intravenous ORIG-1 Exela Pharma Type 5 - New Formulation or New Manufacturer Approved Diclofenac Potassium ANDA #216635 Diclofenac Potassium For Solution; Oral ORIG-1 Alkem Labs Ltd   Approved July 19, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Sensorcaine NDA #018304 Bupivacaine Hydrochloride Injectable; Injection SUPPL-50 Fresenius Kabi Usa Labeling Approved Sensorcaine NDA #018304 Bupivacaine Hydrochloride; Epinephrine Bitartrate Injectable; Injection SUPPL-50 Fresenius Kabi Usa Labeling Approved Lexette NDA #210566 Halobetasol Propionate Aerosol, Foam; Topical SUPPL-5 Mayne Pharma Labeling Approved Aklief NDA #211527 Trifarotene Cream; Topical SUPPL-1 Galderma Labs Lp Labeling Approved Aklief NDA #211527 Trifarotene Cream; Topical SUPPL-1 Galderma Labs Lp Labeling Approved Aklief NDA #211527 Trifarotene Cream; Topical SUPPL-1 Galderma Labs Lp Labeling Approved Pirfenidone ANDA #212722 Pirfenidone Tablet; Oral ORIG-1 Laurus   Approved Pirfenidone ANDA #212724 Pirfenidone Capsule; Oral ORIG-1 Laurus   Approved Pemetrexed NDA #214408 Pemetrexed Solution; Intravenous ORIG-1 Accord Hlthcare Inc Type 3 - New Dosage Form Approved Phenoxybenzamine Hydrochloride ANDA #215042 Phenoxybenzamine Hydrochloride Capsule; Oral ORIG-1 Novitium Pharma   Approved Chlordiazepoxide Hydrochloride and Clidinium Bromide ANDA #215835 Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral ORIG-1 Micro Labs   Approved Norepinephrine Bitartrate ANDA #216341 Norepinephrine Bitartrate Injectable; Injection ORIG-1 Zydus Pharms   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