ARTICLE | Company News
CBST gets Cubicin sNDA approvable letter
March 28, 2006 2:37 AM UTC
Cubist (CBST) received an approvable letter from FDA late Friday for an sNDA for Cubicin daptomycin to treat bacteremia caused by Staphylococcus aureus, including in patients with suspected or proven infective endocarditis. CBST has responded to the letter and hopes to resolve ongoing label negotiations with FDA within 60 days. FDA did not request additional data. ...