CDER New: 5/31/2022

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 May 27, 2022 FDA Drug Shortages Iodixanol (Visipaque) Injection (Updated - Currently in Shortage) Iohexol (Omnipaque) Injection (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. May 27, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Evrysdi NDA #213535 Risdiplam For Solution; Oral SUPPL-3 Genentech Inc Efficacy Approved Evrysdi NDA #213535 Risdiplam For Solution; Oral SUPPL-5 Genentech Inc Efficacy Approved Beovu BLA #761125 Brolucizumab-Dbll Injectable; Intravitreal SUPPL-8 Novartis Pharms Corp Efficacy Approved May 26, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Carac NDA #020985 Fluorouracil Cream; Topical SUPPL-19 Valeant Pharms North Labeling Approved Atnaa NDA #021175 Atropine; Pralidoxime Chloride Injectable; Intramuscular SUPPL-47 Us Army Labeling Approved Atnaa NDA #021175 Atropine; Pralidoxime Chloride Injectable; Intramuscular SUPPL-47 Us Army Labeling Approved Aveed NDA #022219 Testosterone Undecanoate Injectable; Intramuscular SUPPL-19 Endo Pharms Inc REMS Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5185 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5185 Genzyme Labeling Approved Nitisinone ANDA #212390 Nitisinone Capsule; Oral ORIG-1 Dipharma   Approved Paroxetine Hydrochloride ANDA #213612 Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Sinotherapeutics Inc Manufacturing (CMC) Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma Labeling Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma Labeling Approved Alosetron Hydrochloride ANDA #213614 Alosetron Hydrochloride Tablet; Oral SUPPL-7 Mankind Pharma Labeling Approved Pemetrexed NDA #214657 Pemetrexed Solution; Injection ORIG-1 Sandoz Inc Type 5 - New Formulation or New Manufacturer Approved Pemetrexed NDA #214657 Pemetrexed Solution; Intravenous ORIG-1 Sandoz Inc Type 5 - New Formulation or New Manufacturer Approved Arformoterol Tartrate ANDA #215385 Arformoterol Tartrate Solution; Inhalation ORIG-1 Sun Pharm   Approved Atropine Sulfate ANDA #216120 Atropine Sulfate Solution; Intravenous ORIG-1 Am Regent   Approved Bumetanide ANDA #216434 Bumetanide Injectable; Injection ORIG-1 Gland Pharma Ltd   Approved Fylnetra BLA #761084 Pegfilgrastim-Pbbk Injectable; Injection ORIG-1 Kashiv Biosciences Llc Type 2 - New Active Ingredient 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