CDER New: 2/28/2022

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 February 25, 2022 FDA updates Sotrovimab emergency use authorization FDA Drug Shortages Leucovorin Calcium Lyophilized Powder 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. February 24, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Jardiance NDA #204629 Empagliflozin Tablet; Oral SUPPL-33 Boehringer Ingelheim Efficacy Approved Ocaliva NDA #207999 Obeticholic Acid Tablet; Oral SUPPL-8 Intercept Pharms Inc Labeling Approved Epidiolex NDA #210365 Cannabidiol Solution; Oral SUPPL-15 Gw Res Ltd Labeling Approved February 23, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ambien NDA #019908 Zolpidem Tartrate Tablet; Oral SUPPL-40 Sanofi Aventis Us Labeling Approved Ambien NDA #019908 Zolpidem Tartrate Tablet; Oral SUPPL-44 Sanofi Aventis Us Labeling Approved Ambien NDA #019908 Zolpidem Tartrate Tablet; Oral SUPPL-47 Sanofi Aventis Us Labeling Approved Cubicin NDA #021572 Daptomycin Powder; Intravenous SUPPL-68 Cubist Pharms Llc Labeling Approved Cubicin Rf NDA #021572 Daptomycin Powder; Intravenous SUPPL-68 Cubist Pharms Llc Labeling Approved Ambien Cr NDA #021774 Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-21 Sanofi Aventis Us Labeling Approved Ambien Cr NDA #021774 Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-25 Sanofi Aventis Us Labeling Approved Ambien Cr NDA #021774 Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-28 Sanofi Aventis Us Labeling Approved Linezolid ANDA #205517 Linezolid Tablet; Oral SUPPL-4 Alkem Labs Ltd Labeling Approved Aliqopa NDA #209936 Copanlisib Dihydrochloride Powder; Intravenous SUPPL-10 Bayer Healthcare Labeling Approved Apomorphine Hydrochloride ANDA #212025 Apomorphine Hydrochloride Injectable; Subcutaneous ORIG-1 Sage Chems   Approved Succinylcholine Chloride ANDA #214246 Succinylcholine Chloride Injectable; Injection SUPPL-2 Gland Pharma Ltd Labeling Approved Acetylcysteine ANDA #215620 Acetylcysteine Injectable; Intravenous ORIG-1 Indoco   Approved Triamterene and Hydrochlorothiazide ANDA #216211 Hydrochlorothiazide; Triamterene Tablet; Oral ORIG-1 Rubicon   Approved Cablivi BLA #761112 Caplacizumab-Yhdp Injectable; Injection SUPPL-9 Ablynx Nv 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