Please use a PC Browser to access Register-Tadawul
Amneal Resubmits DHE Autoinjector New Drug Application And Receives U.S. FDA Approval Of Exenatide, Its First Generic Injectable GLP-1 Agonist
Amneal Pharmaceuticals, Inc. Class A AMRX | 0.00 |
Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches
Exenatide approval highlights Amneal's capabilities in developing GLP-1 injectables
Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company's first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations.