CDER New: 3/22/2021

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 19, 2021 New Radio PSA and Posters & Postcards for Safe Opioid Disposal - Remove the Risk Outreach Toolkit FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company) Drug Supply Chain Security Act Public-Private Partnership Stakeholder Discussions on PDUFA VII Reauthorization - PDUFA VII: Fiscal Years 2023 – 2027 (updated) Internet Pharmacy Warning Letters (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. March 19, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cutivate NDA #019957 Fluticasone Propionate Ointment; Topical SUPPL-13 Fougera Pharms Labeling Approved Uvadex NDA #020969 Methoxsalen Injectable; Injection SUPPL-14 Mallinckrodt Hosp Labeling Approved Picato NDA #202833 Ingenol Mebutate Gel; Topical SUPPL-13 Leo Labs Labeling Approved Picato NDA #202833 Ingenol Mebutate Gel; Topical SUPPL-13 Leo Labs Labeling Approved March 18, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Propylthiouracil ANDA #080154 Propylthiouracil Tablet; Oral SUPPL-44 Quagen Manufacturing (CMC) Approved Arcalyst BLA #125249 Rilonacept Vial; Single-Use SUPPL-49 Regeneron Pharmaceuticals Efficacy Approved Clindamycin Phosphate ANDA #209914 Clindamycin Phosphate Solution; Topical SUPPL-3 Encube Ethicals Manufacturing (CMC) Approved Tibsovo NDA #211192 Ivosidenib Tablet; Oral SUPPL-7 Agios Pharms Inc Labeling Approved Ponvory NDA #213498 Ponesimod Tablet; Oral ORIG-1 Janssen Pharmaceuticals Inc Type 1 - New Molecular Entity Approved Sarclisa BLA #761113 Isatuximab-Irfc Injectable; Injection SUPPL-4 Sanofi Aventis Us Labeling Approved Sarclisa BLA #761113 Isatuximab-Irfc Injectable; Injection SUPPL-4 Sanofi Aventis Us 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