CDER New: 11/1/2021

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 October 29, 2021 Competitive Generic Therapy Approvals FDA Drug Shortages Cefdinir Powder for Suspension (New - Discontinuation) Lipid Injection (Updated - Currently in Shortage) Guidance for Industry: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Recent New and Generic Drug Approvals This report displays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. October 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Acthar Gel NDA #008372 Corticotropin Injectable; Injection SUPPL-71 Mallinckrodt Ard Labeling Approved Scemblix NDA #215358 Asciminib Tablet; Oral ORIG-1 Novartis Pharms Corp Type 1 - New Molecular Entity Approved Scemblix NDA #215358 Asciminib Tablet; Oral ORIG-2 Novartis Pharms Corp Type 1 - New Molecular Entity Approved October 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Phospholine Iodide NDA #011963 Echothiophate Iodide For Solution; Ophthalmic SUPPL-52 Fera Pharms Llc Labeling Approved Phospholine Iodide NDA #011963 Echothiophate Iodide For Solution; Ophthalmic SUPPL-52 Fera Pharms Llc Labeling Approved Zarontin NDA #012380 Ethosuximide Capsule; Oral SUPPL-37 Parke Davis Labeling Approved Starlix NDA #021204 Nateglinide Tablet; Oral SUPPL-25 Novartis Labeling Approved Oxycontin NDA #022272 Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-47 Purdue Pharma Lp Labeling Approved Tymlos NDA #208743 Abaloparatide Solution; Subcutaneous SUPPL-10 Radius Health Inc Efficacy Tentative Approval Albuterol Sulfate ANDA #209959 Albuterol Sulfate Aerosol, Metered; Inhalation SUPPL-10 Cipla Labeling Approved Albuterol Sulfate ANDA #209959 Albuterol Sulfate Aerosol, Metered; Inhalation SUPPL-10 Cipla Labeling Approved Givlaari NDA #212194 Givosiran Sodium Solution; Subcutaneous SUPPL-4 Alnylam Pharms Inc Labeling Approved Ponvory NDA #213498 Ponesimod Tablet; Oral SUPPL-1 Janssen Pharms Labeling Approved Ponvory NDA #213498 Ponesimod Tablet; Oral SUPPL-1 Janssen Pharms Labeling Approved Pilocarpine Hydrochloride NDA #214028 Pilocarpine Hydrochloride Solution/Drops; Ophthalmic ORIG-1 Abbvie Inc Type 5 - New Formulation or New Manufacturer Approved Diltiazem Hydrochloride NDA #215252 Diltiazem Hydrochloride Solution; Intravenous ORIG-1 Exela Pharma 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