FDA sends approvable letter to Wyeth for Tygacil

WASHINGTON The application for Wyeth’s Tygacil for the treatment of community-acquired pneumonia, received an approvable letter from the Food and Drug Administration, the company announced Tuesday.

The FDA has requested additional analyses of the safety and efficacy of Tygacil when used to treat patients with illness severe enough to require hospitalization, as well as possibly fatal cases.

The FDA originally approved Tygacil, an antibiotic, in 2005 for treating intra-abdominal infections and complicated-skin and skin-structure infections.