CDER New: 7/23/2021

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 22, 2021 FDA Drug Safety Podcast: FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins FDA Drug Shortages Disopyramide Phosphate (Norpace) Capsules (New - Currently in Shortage) Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage) FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma  Field Alert Report Submission: Questions and Answers Guidance for Industry 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 22, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Morphine Sulfate NDA #022195 Morphine Sulfate Solution; Oral SUPPL-20 Hikma Labeling Approved Bydureon NDA #022200 Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-31 Astrazeneca Ab Efficacy Approved Bydureon Pen NDA #022200 Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-31 Astrazeneca Ab Efficacy Approved Bydureon Bcise NDA #209210 Exenatide Suspension, Extended Release; Subcutaneous SUPPL-17 Astrazeneca Ab Efficacy Approved July 21, 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-105 Merck Sharp Dohme Efficacy Approved Oxycodone Hydrochloride NDA #200534 Oxycodone Hydrochloride Capsule; Oral SUPPL-10 Genus Lifesciences Efficacy Approved Oxycodone Hydrochloride NDA #200535 Oxycodone Hydrochloride Solution; Oral SUPPL-17 Genus Lifesciences Efficacy Approved Oxycodone Hydrochloride NDA #201194 Oxycodone Hydrochloride Solution; Oral SUPPL-9 Vistapharm Efficacy Approved Silodosin ANDA #204726 Silodosin Capsule; Oral SUPPL-5 Sandoz Inc Labeling Approved Lenvima NDA #206947 Lenvatinib Mesylate Capsule; Oral SUPPL-20 Eisai Inc 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