Executive Summary

Wyeth anticipates submitting a complete response to FDA's "approvable" letter for a new community-acquired pneumonia indication for its I.V. antibiotic Tygacil (tigecycline) by June 27, the company says after announcing receipt of the letter on May 29. On that timetable, the sNDA would have a user fee goal of Dec. 22. FDA requested additional analyses of the antibiotic "in patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality," Wyeth says. FDA also asked for benefit/risk information on the potential for liver toxicity; Wyeth maintains that such information was presented to FDA during the review period, noting that "the agency acknowledged in its letter that it had not yet reviewed that information.