Cubicin clears FDA
Executive Summary
Cubist's Cubicin, formerly Cidecin (daptomycin for injection) is approved Sept. 12 for treatment of complicated skin and skin structure infections. An FDA "Talk Paper" notes it is the first cyclic lipopeptide antibacterial agent. Cubicin's priority action review date of June 20 had been extended three months after reformatting of data sets (1"The Pink Sheet" June 23, 2003, In Brief)...