Antares Pharma Gets Complete Response Letter For Sumatriptan Injection USP

(RTTNews) - Antares Pharma Inc. (ATRS) announced that the U.S. Food and Drug Administration or FDA has issued a complete response letter regarding the Abbreviated New Drug Application or ANDA 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.

As previously indicated, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equally with Antares Pharma.

Eamonn Hobbs, President and Chief Executive Officer, said, "We are pleased with the feedback received from the FDA in the complete response letter. The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response."