CDER New: 3/31/2022

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 March 30, 2022 FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC) 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. March 30, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Poteligeo BLA #761051 Mogamulizumab-Kpkc Injectable; Injection SUPPL-15 Kyowa Kirin Labeling Approved March 29, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Plegridy BLA #125499 Peginterferon Beta-1a Injectable; Injection SUPPL-25 Biogen Idec Inc Labeling Approved Edurant NDA #202022 Rilpivirine Hydrochloride Tablet; Oral SUPPL-17 Janssen Prods Efficacy Approved Edurant NDA #202022 Rilpivirine Hydrochloride Tablet; Oral SUPPL-18 Janssen Prods Efficacy Approved Vocabria NDA #212887 Cabotegravir Sodium Tablet; Oral SUPPL-5 Viiv Hlthcare Efficacy Approved Vocabria NDA #212887 Cabotegravir Sodium Tablet; Oral SUPPL-6 Viiv Hlthcare Efficacy Approved Cabenuva Kit NDA #212888 Cabotegravir; Rilpivirine Suspension, Extended Release; Intramuscular SUPPL-5 Viiv Hlthcare Efficacy Approved Cabenuva Kit NDA #212888 Cabotegravir; Rilpivirine Suspension, Extended Release; Intramuscular SUPPL-6 Viiv Hlthcare Efficacy Approved Nifedipine ANDA #216067 Nifedipine Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd   Approved Fluoxetine Hydrochloride ANDA #216232 Fluoxetine Hydrochloride Capsule; Oral ORIG-1 Micro Labs   Approved March 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Caprelsa NDA #022405 Vandetanib Tablet; Oral SUPPL-19 Genzyme Corp Labeling Approved Caprelsa NDA #022405 Vandetanib Tablet; Oral SUPPL-19 Genzyme Corp Labeling Approved Exemestane ANDA #206421 Exemestane Tablet; Oral SUPPL-6 Amneal Pharms Labeling Approved Exemestane ANDA #206421 Exemestane Tablet; Oral SUPPL-6 Amneal Pharms Labeling Approved Testosterone Undecanoate NDA #208088 Testosterone Undecanoate Capsule; Oral ORIG-1 Antares Pharma Inc Type 3 - New Dosage Form Approved Levetiracetam ANDA #209474 Levetiracetam Injectable; Intravenous ORIG-1 Prinston Inc   Approved Oseltamivir Phosphate ANDA #209590 Oseltamivir Phosphate For Suspension; Oral ORIG-1 Hetero Labs Ltd V   Approved Ozempic NDA #209637 Semaglutide Solution; Subcutaneous SUPPL-9 Novo Efficacy Approved Alyq ANDA #209942 Tadalafil Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved Alyq ANDA #209942 Tadalafil Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved Alyq ANDA #209942 Tadalafil Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved Dextrose 5% and Lactated Ringer's ANDA #210332 Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate Injectable; Injection ORIG-1 Fresenius Kabi Usa   Approved Xpovio NDA #212306 Selinexor Tablet; Oral SUPPL-10 Karyopharm Theraps Labeling Approved Abiraterone Acetate ANDA #212462 Abiraterone Acetate Tablet; Oral SUPPL-4 Qilu Labeling Approved Ramelteon ANDA #213186 Ramelteon Tablet; Oral SUPPL-4 Granules Labeling Approved Prednisone ANDA #215672 Prednisone Tablet; Oral ORIG-1 Aurobindo Pharma Ltd   Approved Hyrimoz BLA #761071 Adalimumab-Adaz Injectable; Injection SUPPL-11 Sandoz Inc Manufacturing (CMC) 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