Antares Pharma provides regulatory update on migraine treatment

WATSON PHARMACEUTICALS, INC. LOGO

Antares Pharma, Inc announced on Monday that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Company’s first ANDA approval and second device approved from the VIBEX® auto injector platform.

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