Amneal receives u.s. fda approval for brekiya® (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults

Brekiya® becomes the first and only dhe autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form product will be available for appropriate patients in the second half of 2025 bridgewater, n.j., may 15, 2025 (globe newswire) -- amneal pharmaceuticals, inc. (nasdaq: amrx) (“amneal” or the “company”) today announced that the u.s. food and drug administration (fda) has approved brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (dhe) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 brekiya autoinjector provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1 , 3 ,4 it contains the same medication (dhe) used in hospitals, now in a ready-to-use device.1, 5 brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 patients can deliver one dose subcutaneously into the middle of the thigh.1 this may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1 ,5 ,6          “we are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches.
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