The US Food and Drug Administration (FDA) has approved Antares Pharma, Inc's Abbreviated New Drug Application (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, a selective serotonin receptor agonist, represents the company’s first ANDA approval of a complex generic and second product approved using the Vibex auto injector platform. In accordance with our previously disclosed agreement, Teva Pharmaceutical Industries, Ltd. (Teva) will distribute the product through their US generic division and share the profits equally with Antares Pharma.

Eamonn P. Hobbs, president and chief executive officer, stated, “Today’s announcement represents the second combination drug/device approval for Antares, and the company’s first ANDA approval of a therapeutically equivalent complex generic. We are pleased to be able to offer this product to patients in the United States through our partner, Teva. We believe that the approval of the ANDA for Sumatriptan injection USP demonstrates our strength in bringing combination products to market and we remain optimistic about our other combination product development programs, including the generic epinephrine pen and generic exenatide pen, both currently under review at the FDA and QuickShot Testosterone for the treatment of adult males diagnosed with low testosterone, currently in the clinical trial phase. We believe that continuing to develop additional drug/device combination products and leveraging our expertise in this area either through our complex generics business, our alliance business or our proprietary products business will ultimately result in continued revenue growth of the company.”

In November 2012, Antares Pharma entered into a license, supply and distribution agreement with Teva for an auto injector product containing sumatriptan for the treatment of migraines. Teva will manufacture and supply the drug product to Antares. Antares will manufacture the device and be responsible for the assembly and packaging of the final product, which will then be sold to Teva at our cost. Teva will distribute the product in the US and the net profits, after an allowance for a fixed percentage cost of distribution, will be split equally between the companies. Teva also received an option for rights to the product in other territories. The term of the agreement is seven years from commercial launch, with automatic one-year renewals unless terminated by either party pursuant to the provisions of the agreement. Antares Pharma and Teva currently expect to launch the product in June of 2016.

The most common side effects of Sumatriptan injection include injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.