dihydroergotamine prefilled syringe autoinjector / Amneal - LARVOL DELTA

Amneal files again for FDA approval of first dihydroergotamine autoinjector (Yahoo Finance) - "Amneal Pharmaceuticals has submitted another new drug application (NDA) for its dihydroergotamine (DHE) prefilled syringe autoinjector to treat tough-to-treat headaches, after being previously rejected. The resubmitted filing to the US Food and Drug Administration (FDA) addresses manufacturing concerns raised by the agency when it issued Amneal a complete response letter (CRL). A review of the NDA, which is for the acute treatment of migraine with or without aura and cluster headache in adults, is expected to be completed in Q2 2025, as per a 21 November press release."

FDA filing • CNS Disorders • Migraine • Pain

Amneal Pharmaceuticals, inc (AMRX) Q3 2021 Earnings Call Transcript (The Motley Fool) - "First, our ANDA for the DHE autoinjector for migraine and cluster headache is pending FDA approval with launch expected in mid-2022."

Generic launch • Chronic Cluster Headache • CNS Disorders • Migraine • Pain

"$AMRX Amneal Announces Dihydroergotamine (DHE) Autoinjector NDA for Migraines and Cluster Headaches https://t.co/tTL3O8nBqN" (@stock_titan)

NDA • CNS Disorders • Migraine • Pain

Amneal Announces Dihydroergotamine (DHE) Autoinjector NDA for Migraines and Cluster Headaches (Businesswire) - "Amneal Pharmaceutical...announced that the Food and Drug Administration recently accepted Amneal’s 505(b)(2) New Drug Application for a newly licensed dihydroergotamine (DHE) prefilled syringe autoinjector and the company said it anticipates a decision by the middle of 2022. If approved, Amneal anticipates a commercial launch in the second half of 2022. Amneal plans to commercialize the product solely in the U.S. market...The proposed indication for the product is acute migraine with and without aura and cluster headache in adults."

Launch US • NDA • CNS Disorders • Migraine • Pain