The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ Brekiya (dihydroergotamine (DHE) mesylate) autoinjector for the treatment of acute migraine with or without aura and cluster headaches in the adult population.
This makes Brekiya the first DHE autoinjector for treating these conditions.
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The autoinjector offers potential pain relief and is designed for self-administration, eliminating the need for refrigeration, priming or assembly.
It allows patients to administer the dose subcutaneously into the middle part of their thigh – particularly beneficial for those who do not have an adequate response to the oral treatments or experience nausea and vomiting during the attacks.
DHE is commonly used in medical facilities for migraine and can be administered at any stage of an attack to help prevent recurrence.
The product will be available for eligible individuals in the second half of 2025.
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By GlobalDataIt offers an alternative for individuals suffering from cluster headaches – up to now a condition with limited treatment options.
Amneal Pharmaceuticals Specialty chief commercial officer and senior vice-president Joe Renda stated: “We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches.
“Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks, without visiting the emergency room.”
In April 2025 Amneal, in partnership with Shilpa Medicare, introduced Boruzu, a new bortezomib presentation for subcutaneous or intravenous use, aimed at treating individuals with multiple myeloma and mantle cell lymphoma in the US. Boruzu is the first ready-to-use bortezomib injection, simplifying the preparation process required for administration.
In March 2024, the company announced the FDA’s approval of an abbreviated new drug application for its ciprofloxacin and dexamethasone otic suspension. This generic version of Novartis’ Ciprodex is indicated for ear infections.
