Aventis submits additional Ketek information
Executive Summary
Aventis submits additional analysis of clinical studies and postmarketing surveillance data in response to FDA's Jan. 24 "approvable" letter for antibiotic Ketek (telithromycin). The company filed additional safety data in 2002 following a June 2001 "approvable" letter (1"The Pink Sheet" Nov. 4, 2002, p. 16)...