Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requested that Wyeth provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk of TYGACIL for any potential of liver toxicity. Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information.
The details can be read here.
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