Amneal Resubmits Migraine Treatment Application and Receives FDA Approval for Diabetes Drug
Key Insights
Amneal Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for dihydroergotamine, a migraine (search) treatment administered via a single-dose autoinjector.
The original application was rejected due to facility inspection issues, which Amneal addressed by transferring production in-house, with review completion expected in Q2 2025.
The FDA has approved Amneal's exenatide, a GLP-1 agonist (search), available in 1.2 mL and 2.4 mL pen injections, for managing blood sugar levels in adults with type 2 diabetes (search).
Amneal Pharmaceuticals has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its dihydroergotamine migraine (search) treatment. This follows the FDA's approval of Amneal's exenatide, a GLP-1 agonist (search), for managing blood sugar levels in adults with type 2 diabetes (search). The resubmitted migraine treatment aims to provide a ready-to-use solution for patients suffering from severe migraines and cluster headaches (search).
Migraine Treatment Resubmission
Dihydroergotamine is designed as a single-dose autoinjector that does not require refrigeration, assembly, or priming. This allows patients to self-administer the medication at home when experiencing severe headaches. The original NDA was rejected due to facility inspection issues at a third-party manufacturing site. To address these concerns, Amneal has transferred the production of dihydroergotamine in-house. The FDA is expected to complete its review of the resubmitted application in the second quarter of 2025.
Joe Renda, Chief Commercial Officer, stated, "We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches (search)."
FDA Approves Diabetes Treatment
Amneal also announced the FDA's approval of its GLP-1 agonist (search), exenatide, a synthetic version of the hormone that regulates blood sugar, digestion, and appetite. Exenatide is approved as a pen injection available in 1.2 mL and 2.4 mL doses. It is indicated as an adjunct to diet and exercise to help maintain blood sugar levels in adult patients with type 2 diabetes (search). This approval provides another option for managing type 2 diabetes, a condition affecting millions of adults in the United States.