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FDA delays approval of Wyeth's community-acquired pneumonia drug Tygacil for safety data

www.canadianbusiness.com

Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval.

Tygacil is currently approved to treat adults with complicated intra-abdominal infections and complicated skin infections. The drugmaker filed to expand Tygacil's use to include treating patients with community-acquired pneumonia severe enough to require hospitalization, including those who are at higher risk of death.

In an "approvable" letter, regulators also requested information on Tygacil's risk/benefit profile regarding any potential for liver toxicity. Wyeth said it recently provided that information to the agency, and believes that response is adequate. The FDA has acknowledged it has not yet reviewed the information.

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