The approval was based on results of two randomized, double-blind, active-controlled, multinational studies (studies 308 and 313) that evaluated Tygacil for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
Tygacil was first approved by the FDA in 2005 for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections caused by susceptible strains of indicated pathogens in adults.
Joseph Camardo, senior vice president of global medical affairs at Wyeth Pharmaceuticals, said: “The approval of this new indication is timely. Antibiotic resistance continues to grow and new antimicrobials are needed. The approval of Tygacil for CABP is an important milestone in Wyeth’s commitment to exploring new treatment options in the anti-infective therapeutic area.”