The agency issued an approvable letter for the drugmaker’s Tygacil antibiotic, which Wyeth wants to sell for treating community-acquired pneumonia, which is found beyond hospitals or nursing homes. But the FDA wants more data on severe cases, as well as more info about potential liver toxicity.

Tygacil, which had about $138 million in sales last year and is administered intravenously, won FDA approval in 2005 for treating adults with complicated intra-abdominal infections and complicated skin and skin-structure infections.

At the same time, the FDA granted fast track status to Wyeth’s new version of its Prevnar vaccine for preventing childhood infections with pneumococcal bacteria. The new form would protect against 13 strains of the bacteria, compared with seven currently.

Wyeth plans to complete its filing for pediatric use of the new Prevnar vaccine, which is the drugmaker’s second-biggest product, with sales of about $2.5 billion last year, in early 2009.

Source: Reuters