CDER New: 1/11/2021

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 January 10, 2021 Over-The-Counter Monograph User Fee Program (OMUFA) January 8, 2021 Drug Trials Snapshot: KLISYRI FDA Drug Shortages Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage) Clindamycin Injection, USP (New - Discontinuation) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Etomidate Injection (Updated - Currently in Shortage) Furosemide Injection, USP (Updated - Currently in Shortage) Leuprolide Acetate Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Vecuronium Bromide for Injection (Updated - Currently in Shortage) New Drug Approvals 2020 Report - Advancing Health through Innovation 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 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. January 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Bivalirudin In 0.9% Sodium Chloride NDA #208374 Bivalirudin Solution; Intravenous SUPPL-2 Baxter Hlthcare Corp Labeling Approved Pemetrexed NDA #208746 Pemetrexed Unknown ORIG-1 Hospira Inc   Tentative Approval January 7, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Caduet NDA #021540 Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-46 Pharmacia Labeling Approved Children's Claritin NDA #021891 Loratadine Tablet, Chewable; Oral SUPPL-36 Bayer Healthcare Llc Labeling Approved Claritin NDA #021891 Loratadine Tablet, Chewable; Oral SUPPL-36 Bayer Healthcare Llc Labeling Approved Tadalafil ANDA #211335 Tadalafil Tablet; Oral SUPPL-2 Sunshine Labeling Approved Tadalafil ANDA #211335 Tadalafil Tablet; Oral SUPPL-2 Sunshine Labeling Approved Nubeqa NDA #212099 Darolutamide Tablet; Oral SUPPL-1 Bayer Healthcare Efficacy 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