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Wyeth Pharma's SNDA for Tygacil accepted by US FDA |
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Written by Administrator
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Thursday, 25 October 2007 |
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The US Food and Drug Administration has accepted Wyeth Pharmaceuticals’s supplemental new drug application for the treatment of patients with community-acquired pneumonia (CAP).
The US Food and Drug Administration has accepted Wyeth Pharmaceuticals’s supplemental new drug application for its first-in-class antibiotic Tygacil for the treatment of patients with community-acquired pneumonia, or CAP. The company said the SNDA submission included integrated data from two investigational clinical studies that included 846 patients. According to the company’s study data Tygacil cured 89.7% of patients hospitalized with CAP. The most common adverse events for Tygacil were nausea, vomiting and abdominal pain, the company said. |
