CDER New: 7/12/2021

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 July 9, 2021 FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes (new) Public Notifications: X Rated Honey For Men contains hidden drug ingredient Cholestene contains hidden drug ingredient FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products (update) Orange Book Orange Book Current Cumulative Supplement (updated) Additions/Deletions for Prescription and OTC Drug Product Lists (updated) Orange Book Data Files (compressed) (updated) Reference Listed Drugs by ANDA Reference Standard List (updated) Orange Book Patent Listing Dispute List (updated) Appendix A: Product Name Index (updated) Appendix B: Product Name Sorted by Applicant (updated) Appendix C: Uniform Terms (updated) 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. July 9, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Visudyne NDA #021119 Verteporfin Injectable; Injection SUPPL-29 Valeant Luxembourg Labeling Approved Armonair Digihaler NDA #208798 Fluticasone Propionate Powder; Inhalation SUPPL-8 Teva Pharm Efficacy Approved Armonair Respiclick NDA #208798 Fluticasone Propionate Powder; Inhalation SUPPL-8 Teva Pharm Efficacy Approved Airduo Digihaler NDA #208799 Fluticasone Propionate; Salmeterol Xinafoate Powder; Inhalation SUPPL-21 Teva Pharm Efficacy Approved Airduo Respiclick NDA #208799 Fluticasone Propionate; Salmeterol Xinafoate Powder; Inhalation SUPPL-21 Teva Pharm Efficacy Approved Padcev BLA #761137 Enfortumab Vedotin-Ejfv Injectable; Injection SUPPL-8 Astellas Efficacy Approved Padcev BLA #761137 Enfortumab Vedotin-Ejfv Injectable; Injection SUPPL-6 Astellas Efficacy Approved July 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Wellbutrin Xl NDA #021515 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-43 Bausch Labeling Approved Aplenzin NDA #022108 Bupropion Hydrobromide Tablet, Extended Release; Oral SUPPL-21 Bausch Labeling Approved Poteligeo BLA #761051 Mogamulizumab-Kpkc Injectable; Injection SUPPL-11 Kyowa Kirin 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