Genesoft Factive review
Executive Summary
Anti-Infectives Drugs Advisory Committee will review Genesoft's Factive (gemifloxacin) for community-acquired pneumonia and acute exacerbation of chronic bronchitis at its March 4 meeting. Factive received a "not approvable" letter from FDA in December 2000 under an application sponsored by SmithKline Beecham. Following its merger with Glaxo, GSK returned rights for Factive to LG Life Sciences, which then licensed the drug to South San Francisco-based Genesoft. The meetings will be held at the Marriott Washingtonian Center in Gaithersburg, Md. beginning at 8 a.m. on March 4 and 9 a.m. on March 5...