Antares and Teva file sNDA for needle-free injection drug label

This submission is the result of clinical testing and drug-device interaction studies performed over the past 18 months. The sNDA filing also references the 510(k) previously filed by Antares in 2006.

The FDA has required this supplemental filing since needle-free injection is a new route of administration for this product; a needle and syringe is the current route of administration. The FDA review cycle generally takes four to six months to complete with potential FDA approval in the fourth quarter of 2008.

Jack Stover, CEO and vice chairman of Antares, said: “We look forward to progressing with our partners to approval, whereupon we expect to recognize important revenues based on sales of our devices and royalties on the product.”