CDER New: 11/30/2021

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 November 29, 2021 FDA Drug Shortages Dexmedetomidine Injection (Updated - Currently in Shortage) Real-World Data:  Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated) Final Agenda for the November 30, 2021 Meeting of the Antimicrobial Drugs Advisory Committee (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. November 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Intron A BLA #103132 Interferon Alfa-2b Vial SUPPL-5202 Schering Labeling Approved Detroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #214403 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Lannett Co Inc   Approved Daptomycin ANDA #215215 Daptomycin Powder; Intravenous ORIG-1 Hangzhou Zhongmei   Approved Atropine Sulfate ANDA #215624 Atropine Sulfate Solution/Drops; Ophthalmic ORIG-1 Apotex Inc   Approved November 24, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Buprenorphine Hydrochloride ANDA #078633 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-24 Hikma Labeling Approved Lansoprazole ANDA #203187 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved Lansoprazole ANDA #203187 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-3 Mylan Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #205022 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #205022 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Lannett Co Inc 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