Brekiya (dihydroergotamine prefilled syringe autoinjector) / Amneal - LARVOL DELTA

Amneal Reports Third Quarter 2025 Financial Results (The Manila Times) - "CREXONT for Parkinson’s disease and other key branded products continue to drive Specialty growth, complemented by the launch this month of BREKIYA in the migraine space...Net revenue in the third quarter of 2025 was $785 million, an increase of 12% compared to $702 million in the third quarter of 2024. Specialty net revenue increased 8% driven by key branded products, including CREXONT and UNITHROID."

Commercial • Migraine • Pain • Parkinson's Disease

US FDA approves Amneal's self-administered migraine treatment (Reuters) - "The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals...self-administered migraine drug, giving way to a quick and more convenient treatment option for patients. The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday."

FDA approval • Migraine • Pain

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