Amneal Targets Migraine With 505(b)(2) Filing

Pursues Headache Market In US With Dihydroergotamine Autoinjector

Amneal is setting its sights on the migraine and cluster headache market in the US with a new hybrid 505(b)(2) filing for a dihydroergotamine autoinjector.

Headache Migraine Pain
Amneal is targeting migraine and cluster headache • Source: Alamy

Amneal says it will leverage its commercial infrastructure and experience in the neurology space to capitalize on its latest product opportunity, a hybrid 505(b)(2) filing for a dihydroergotamine pre-filled syringe autoinjector aimed at the migraine and cluster headache market in the US.

Announcing the US Food and Drug Administration’s acceptance of its 505(b)(2) new drug application, Amneal said it “anticipates a decision...

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