Antares Pharma, Inc. (ANTR) and Teva Pharmaceutical Industries Limited (TEVA) Announce Filing of sNDA for Needle-Free Injector with Human Growth Hormone
7/29/2008 11:37:58 AM
EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (AMEX:AIS), a specialty pharmaceutical company focused on improving pharmaceuticals through advanced drug delivery systems, and its partner, Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) today announced the filing of a Supplemental New Drug Application (sNDA) in order to add “needle-free injection” to the product 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.