FDA requests additional testing on Wyeth’s Tygacil

NEW YORK The Food and Drug Administration has placed a hold on approval for Wyeth Pharmaceuticals’ new antibiotic Tygacil pending additional tests on its safety and effectiveness, the company announced Thursday.

The regulatory agency is requiring Wyeth to further test how safe and effective Tygacil is in treating community-acquired pneumonia, which is pneumonia contracted outside a healthcare facility. The FDA has approved Tygacil for treating complicated skin infections and intra-abdominal infections.

Based in Collegeville, Pa., Wyeth develops and markets pharmaceuticals, consumer healthcare products and animal healthcare products.