CDER New: 7/29/2022

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 28, 2022 Public Notification: Honeymoon Exclusive For Men & Women contains hidden drug ingredients Competitive Generic Therapy Approvals (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 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cotellic NDA #206192 Cobimetinib Fumarate Tablet; Oral SUPPL-4 Genentech Inc Efficacy Approved July 27, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Estring NDA #020472 Estradiol Insert, Extended Release; Vaginal SUPPL-19 Pfizer Labeling Approved Estring NDA #020472 Estradiol Insert, Extended Release; Vaginal SUPPL-19 Pfizer Labeling Approved Mesalamine ANDA #091640 Mesalamine Tablet, Delayed Release; Oral SUPPL-18 Zydus Pharms Labeling Approved Gazyva BLA #125486 Obinutuzumab Injectable; Injection SUPPL-34 Genentech Labeling Approved Taltz BLA #125521 Ixekizumab Injectable; Injection SUPPL-24 Eli Lilly and Co Labeling Approved Taltz BLA #125521 Ixekizumab Injectable; Injection SUPPL-24 Eli Lilly and Co Labeling Approved Paclitaxel NDA #211875 Paclitaxel For Suspension; Iv (Infusion) ORIG-1 Hbt Labs Inc Type 5 - New Formulation or New Manufacturer Approved Diclofenac Sodium ANDA #212351 Diclofenac Sodium Gel; Topical ORIG-1 Aleor Dermaceuticals   Approved Clopidogrel Bisulfate ANDA #213351 Clopidogrel Bisulfate Tablet; Oral SUPPL-1 Polygen Pharms Labeling Approved Clopidogrel Bisulfate ANDA #213351 Clopidogrel Bisulfate Tablet; Oral SUPPL-1 Polygen Pharms Labeling Approved Kyzatrex NDA #213953 Testosterone Undecanoate Capsule; Oral ORIG-1 Marius Pharmaceuticals, Llc Type 5 - New Formulation or New Manufacturer Approved Vancomycin Hydrochloride ANDA #215196 Vancomycin Hydrochloride Injectable; Injection ORIG-1 Nanjing King-Friend   Approved Bortezomib NDA #215331 Bortezomib Injectable; Intravenous, Subcutaneous ORIG-1 Maia Pharms Inc Type 5 - New Formulation or New Manufacturer Approved Acetaminophen ANDA #216617 Acetaminophen Solution; Intravenous ORIG-1 Aspiro   Approved Adbry BLA #761180 Tralokinumab Injectable; Injection SUPPL-2 Leo Pharma As 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