LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals (NASDAQ: CBST) said today that it believes that no generic manufacturer acted last September to secure a potential “first to file” advantage, by filing an abbreviated new drug application (ANDA) for daptomycin. If such a filing had occurred, the generic company would have had to notify Cubist within 20 days of acceptance of the ANDA by the FDA. It is now a full six months since September 12, 2007—the first opportunity for a generic company to file an ANDA and the only date on which a generic company could be assured of securing the “first to file” advantages available under the Hatch-Waxman legislation—and Cubist has received no notification.
