CDER New: 2/25/2021

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 February 24, 2021 Public Notification: Alpha Male Plus contains hidden drug ingredient FDA Drug Shortages Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage) Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage) 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. February 24, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Humira BLA #125057 Adalimumab Syringe SUPPL-417 Abbvie Inc Efficacy Approved Humira BLA #125057 Adalimumab Vial SUPPL-417 Abbvie Inc Efficacy Approved Fludeoxyglucose F18 ANDA #204333 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-5 Ma General Hosp Labeling Approved February 23, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ezetimibe and Simvastatin ANDA #201890 Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved Ezetimibe and Simvastatin ANDA #201890 Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved Fludeoxyglucose F18 ANDA #204385 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-2 Childrens Hosp Mi Labeling Approved Ezetimibe and Simvastatin ANDA #209222 Ezetimibe; Simvastatin Tablet; Oral SUPPL-8 Alkem Labs Ltd Labeling Approved Everolimus ANDA #210130 Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved Everolimus ANDA #210130 Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved Rufinamide ANDA #213410 Rufinamide Suspension; Oral ORIG-1 Alkem Labs Ltd   Approved Pemazyre NDA #213736 Pemigatinib Tablet; Oral SUPPL-1 Incyte Corp Labeling Approved Acetaminophen, Aspirin and Caffeine ANDA #214039 Acetaminophen; Aspirin; Caffeine Tablet; Oral ORIG-1 Granules   Approved Pemetrexed NDA #214218 Pemetrexed Injectable; Injection ORIG-1 Hospira Inc Type 5 - New Formulation or New Manufacturer Tentative Approval 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