CDER New: 3/17/2021

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 March 16, 2021 Drugs@FDA Data Files (updated) FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy From Our Perspective: FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials Office of New Drugs (OND) | Annual Reports Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments 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 16, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-91 Merck Sharp Dohme Efficacy Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-93 Merck Sharp Dohme Efficacy Approved Sympazan NDA #210833 Clobazam Film; Oral SUPPL-2 Aquestive Labeling Approved Xenleta NDA #211672 Lefamulin Acetate Tablet; Oral SUPPL-2 Nabriva Labeling Approved Xenleta NDA #211673 Lefamulin Acetate Solution; Intravenous SUPPL-2 Nabriva Labeling Approved March 15, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Fludeoxyglucose F18 ANDA #203591 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-1 Sofie Labeling Approved Fludeoxyglucose F18 ANDA #203591 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-1 Sofie Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #204431 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-19 Ethypharm Usa Corp Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #204431 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-19 Ethypharm Usa Corp Labeling Approved Palonosetron Hydrochloride ANDA #204615 Palonosetron Hydrochloride Injectable; Intravenous ORIG-1 Accord Hlthcare   Approved Radicava NDA #209176 Edaravone Solution; Intravenous SUPPL-10 Mitsubishi Tanabe Labeling Approved Divalproex Sodium ANDA #214462 Divalproex Sodium Tablet, Extended Release; Oral ORIG-1 Amta   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