CDER New: 9/2/2022

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 September 1, 2022 CDER Statement: FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute   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. September 1, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Activase BLA #103172 Alteplase Vial; Single-Use SUPPL-5268 Genentech Labeling Approved Activase BLA #103172 Alteplase Vial; Single-Use SUPPL-5268 Genentech Labeling Approved Cathflo Activase BLA #103172 Alteplase Vial SUPPL-5268 Genentech Labeling Approved Cathflo Activase BLA #103172 Alteplase Vial SUPPL-5268 Genentech Labeling Approved Clindamycin Phosphate In 0.9% Sodium Chloride NDA #208083 Clindamycin Phosphate Solution; Intravenous SUPPL-6 Baxter Hlthcare Corp Labeling Approved Clindamycin Phosphate In 0.9% Sodium Chloride NDA #208083 Clindamycin Phosphate Solution; Intravenous SUPPL-7 Baxter Hlthcare Corp Labeling Approved Clindamycin Phosphate In 0.9% Sodium Chloride NDA #208083 Clindamycin Phosphate Solution; Intravenous SUPPL-8 Baxter Hlthcare Corp Labeling Approved Kerendia NDA #215341 Finerenone Tablet; Oral SUPPL-1 Bayer Hlthcare Efficacy Approved August 31, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Furosemide NDA #018667 Furosemide Injectable; Injection SUPPL-43 Hospira Labeling Approved Diprivan NDA #019627 Propofol Injectable; Injection SUPPL-69 Fresenius Kabi Usa Labeling Approved Alimta NDA #021462 Pemetrexed Disodium Powder; Intravenous SUPPL-55 Lilly Efficacy Approved Risperidone ANDA #077494 Risperidone Tablet, Orally Disintegrating; Oral SUPPL-18 Par Pharm Labeling Approved Risperidone ANDA #077494 Risperidone Tablet, Orally Disintegrating; Oral SUPPL-20 Par Pharm Labeling Approved Risperidone ANDA #077494 Risperidone Tablet, Orally Disintegrating; Oral SUPPL-18 Par Pharm Labeling Approved Risperidone ANDA #077494 Risperidone Tablet, Orally Disintegrating; Oral SUPPL-20 Par Pharm Labeling Approved Tenofovir Disoproxil Fumarate ANDA #203232 Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-16 Macleods Pharms Ltd Manufacturing (CMC) Approved Medroxyprogesterone Acetate ANDA #212844 Medroxyprogesterone Acetate Injectable; Injection ORIG-1 Eugia Pharma   Approved Regadenoson ANDA #214349 Regadenoson Solution; Intravenous ORIG-1 Hospira   Approved Xenpozyme BLA #761261 Olipudase Alfa-Rpcp Injectable; Injection ORIG-1 Genzyme Corp Type 1 - New Molecular Entity 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