Antares Pharma Gets FDA Approval For Sumatriptan Injection USP - Quick Facts

(RTTNews) - Antares Pharma, Inc. (ATRS, AIS) said that the U.S. Food and Drug Administration or FDA has approved its Abbreviated New Drug Application or ANDA for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established.

The reference listed drug in the ANDA was GlaxoSmithKline's Imitrex Injection. Sumatriptan Injection USP represents Antares Pharma's first ANDA approval of a complex generic and second product approved using the Vibex auto injector platform.

Antares Pharma noted that in accordance with its previously disclosed agreement, Teva Pharmaceutical Industries, Ltd. (TEVA) will distribute the product through their U.S. generic division and share the profits equally with Antares Pharma.