US FDA

CDER New: 3/28/2023

US FDA sent this email to their subscribers on March 28, 2023.

ADMINISTRATION RN LR LU

What's New Related to Drugs

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 27, 2023

March 24, 2023


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ADMINISTRATION RN LR LU 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 24, 2023 * FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome * FDA Drug Shortages * Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) * Hydrocortisone Sodium Succinate Injection (New - Currently in Shortage) * Ketamine Injection (Updated - Currently in Shortage) * Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) 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 27, 2023 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Veltassa NDA #205739 Patiromer Sorbitex Calcium Powder; Oral SUPPL-37 Vifor Pharma Labeling Approved Narcan NDA #208411 Naloxone Hydrochloride Spray, Metered; Nasal SUPPL-7 Emergent Labeling Approved Narcan NDA #208411 Naloxone Hydrochloride Spray, Metered; Nasal SUPPL-7 Emergent Labeling Approved MARCH 24, 2023 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Thalomid NDA #020785 Thalidomide Capsule; Oral SUPPL-71 Celgene REMS Approved Revlimid NDA #021880 Lenalidomide Capsule; Oral SUPPL-67 Celgene REMS Approved Absorica NDA #021951 Isotretinoin Capsule; Oral SUPPL-22 Sun Pharm Inds Inc REMS Approved Amnesteem ANDA #075945 Isotretinoin Capsule; Oral SUPPL-46 Mylan Pharms Inc REMS Approved Claravis ANDA #076135 Isotretinoin Capsule; Oral SUPPL-60 Teva Pharms Usa REMS Approved Claravis ANDA #076356 Isotretinoin Capsule; Oral SUPPL-55 Teva Pharms Usa REMS Approved Lenalidomide ANDA #201452 Lenalidomide Capsule; Oral SUPPL-6 Arrow Intl REMS Approved Zenatane ANDA #202099 Isotretinoin Capsule; Oral SUPPL-33 Dr Reddys Labs Ltd REMS Approved Fenofibrate ANDA #202856 Fenofibrate Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved Pomalyst NDA #204026 Pomalidomide Capsule; Oral SUPPL-31 Bristol REMS Approved Fetzima NDA #204168 Levomilnacipran Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Abbvie Efficacy Approved Isotretinoin ANDA #205063 Isotretinoin Capsule; Oral SUPPL-5 Actavis Labs Fl REMS Approved Isotretinoin ANDA #207792 Isotretinoin Capsule; Oral SUPPL-24 Amneal Pharms Ny REMS Approved Pregabalin ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Pregabalin ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Pregabalin ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Her Style ANDA #207976 Levonorgestrel Tablet; Oral SUPPL-6 Novast Labs Labeling Approved Lenalidomide ANDA #209348 Lenalidomide Capsule; Oral SUPPL-4 Dr Reddys REMS Approved Lenalidomide ANDA #210154 Lenalidomide Capsule; Oral SUPPL-2 Zydus Pharms REMS Approved Lenalidomide ANDA #210435 Lenalidomide Capsule; Oral SUPPL-2 Cipla REMS Approved Lenalidomide ANDA #210480 Lenalidomide Capsule; Oral SUPPL-3 Lotus Pharm Co Ltd REMS Approved Lenalidomide ANDA #211022 Lenalidomide Capsule; Oral SUPPL-2 Apotex REMS Approved Lenalidomide ANDA #211846 Lenalidomide Capsule; Oral SUPPL-1 Sun Pharm REMS Approved Loratadine ANDA #211900 Loratadine Capsule; Oral ORIG-1 Aurobindo Pharma   Approved Absorica Ld NDA #211913 Isotretinoin Capsule; Oral SUPPL-10 Sun Pharm REMS Approved Isotretinoin ANDA #212333 Isotretinoin Capsule; Oral SUPPL-8 Upsher Smith Labs REMS Approved Lenalidomide ANDA #213405 Lenalidomide Capsule; Oral SUPPL-1 Torrent REMS Approved Evrysdi NDA #213535 Risdiplam For Solution; Oral SUPPL-8 Genentech Inc Manufacturing (CMC) Approved Isotretinoin ANDA #213571 Isotretinoin Capsule; Oral SUPPL-7 Upsher Smith Labs REMS Approved Tabrecta NDA #213591 Capmatinib Hydrochloride Tablet; Oral SUPPL-7 Novartis Pharm Labeling Approved Tabrecta NDA #213591 Capmatinib Hydrochloride Tablet; Oral SUPPL-7 Novartis Pharm Labeling Approved Lenalidomide ANDA #213885 Lenalidomide Capsule; Oral SUPPL-1 Eugia Pharma REMS Approved Lenalidomide ANDA #213912 Lenalidomide Capsule; Oral SUPPL-2 Mylan REMS Approved Pregabalin ANDA #214322 Pregabalin Capsule; Oral SUPPL-3 Changzhou Pharm Labeling Approved Aminocaproic Acid ANDA #214458 Aminocaproic Acid Solution; Oral ORIG-1 Taro Pharms   Approved Lenalidomide ANDA #214618 Lenalidomide Capsule; Oral SUPPL-1 Cipla REMS Approved Quviviq NDA #214985 Daridorexant Hydrochloride Tablet; Oral SUPPL-4 Idorsia Labeling Approved Quviviq NDA #214985 Daridorexant Hydrochloride Tablet; Oral SUPPL-4 Idorsia Labeling Approved Carbamazepine ANDA #216193 Carbamazepine Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd   Approved Dicyclomine Hydrochloride ANDA #216639 Dicyclomine Hydrochloride Capsule; Oral ORIG-1 Corepharma   Approved Levothyroxine Sodium ANDA #217066 Levothyroxine Sodium Powder; Intravenous ORIG-1 Zydus Pharms   Approved Joenja NDA #217759 Leniolisib Phosphate Tablet; Oral ORIG-1 Pharming Technologies Bv Type 1 - New Molecular Entity Approved feedtwitterfacebookyoutubeflickr Manage Subscriptions  |   |  Help ---------------------------------------------------------------------------------------------------------------------------------- This email was sent to 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 GovDelivery logo gOVDELlVERY
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