Amneal Pharmaceuticals (AMRX) announced that the FDA has approved Brekiya injection, the first and only dihydroergotamine autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. The product will be available for appropriate patients in the second half of 2025.

Brekiya autoinjector provides patients with the potential for sustained pain relief in a self-administered form. It contains the same medication used in hospitals, now in a ready-to-use device. Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.

Shares of Amneal Pharmaceuticals are up 6% in pre-market trade on Thursday.

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