CDER New: 6/1/2021

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 May 28, 2021 FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC FDA Drug Shortages Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) Furosemide Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Propofol Injectable Emulsion (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Timolol Maleate Ophthalmic Gel Forming Solution (Updated - Currently in Shortage) Vecuronium Bromide for 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. May 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Vancomycin Hydrochloride NDA #211962 Vancomycin Hydrochloride Solution; Intravenous SUPPL-9 Xellia Pharms Aps Efficacy Approved Truseltiq NDA #214622 Infigratinib Capsule; Oral ORIG-1 Qed Therapeutics Inc Type 1 - New Molecular Entity Approved Lumakras NDA #214665 Sotorasib Tablet; Oral ORIG-1 Amgen Inc Type 1 - New Molecular Entity Approved May 27, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Solu-Cortef NDA #009866 Hydrocortisone Sodium Succinate Injectable; Injection SUPPL-115 Pharmacia and Upjohn Labeling Approved Depo-Medrol NDA #011757 Methylprednisolone Acetate Injectable; Injection SUPPL-120 Pfizer Labeling Approved Solu-Medrol NDA #011856 Methylprednisolone Sodium Succinate Injectable; Injection SUPPL-136 Pharmacia and Upjohn Labeling Approved Juxtapid NDA #203858 Lomitapide Mesylate Capsule; Oral SUPPL-22 Amryt REMS Approved Atorvastatin Calcium ANDA #205519 Atorvastatin Calcium Tablet; Oral SUPPL-24 Sciegen Pharms Inc Labeling Approved Atorvastatin Calcium ANDA #205519 Atorvastatin Calcium Tablet; Oral SUPPL-25 Sciegen Pharms Inc Labeling Approved Nuzyra NDA #209816 Omadacycline Tosylate Tablet; Oral SUPPL-11 Paratek Pharms Inc Efficacy Approved Nuzyra NDA #209817 Omadacycline Tosylate Powder; Intravenous SUPPL-10 Paratek Pharms Inc Efficacy Approved Zeposia NDA #209899 Ozanimod Hydrochloride Capsule; Oral SUPPL-1 Celgene Intl Efficacy Approved Deferasirox ANDA #212669 Deferasirox Tablet; Oral ORIG-1 Celltrion   Approved Nurtec Odt NDA #212728 Rimegepant Sulfate Tablet, Orally Disintegrating; Oral SUPPL-6 Biohaven Pharm Efficacy Approved Loperamide Hydrochloride and Simethicone ANDA #214541 Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Guardian Drug   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