FDA Issues Approvable Letter For Cubist Pharmaceuticals, Inc. (CBST)'s CUBICIN sNDA
3/27/2006 10:49:31 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--March 24, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that it has received an Approvable Letter from the U.S. Food & Drug Administration (FDA) for the sNDA for CUBICIN(R) (daptomycin for injection). The sNDA seeks a label expansion for CUBICIN based on the results of the company's landmark Phase 3 study of CUBICIN once-a-day at 6 mg/kg for the treatment of Staphylococcus aureus (S. aureus) bacteremia and endocarditis. This trial was the first prospective, randomized and controlled registration study of these infections. The Approvable Letter indicates that Cubist's application is approvable, subject to the FDA and Cubist reaching agreement on the label.