Including TYGACIL

– TYGACIL may cause fetal harm when administered during pregnancy – the safety and efficacy of TYGACIL in patients aged below 18 and lactating women have not been studied – Clostridium difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including TYGACIL, and in severity from in severity from mild diarrhea to fatal colitis .

Wyeth Pharmaceuticals – Wyeth Pharmaceuticals, a division of Wyeth , announced that it is withdrawing its application for an extension of European Marketing Authorization for TYGACIL . This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia . Wyeth is the action on the understanding of the Committee for Human Medicinal Products assessment, that the TYGACIL CAP clinical trials not a sufficient number of severely ill CAP patients evaluators based alleviate concerns about efficacy in this subpopulation. TYGACIL is currently approved in Europe for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections in adults. – ‘We are disappointed that we were not able to allay the concerns of the CHMP, and the evaluation of the appropriate next steps to take in Europe,’says Gary L. Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. ‘In October 2007, the U.S. Food and Drug Administration the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, and other regulatory authorities around the world demonstrate the safety and effectiveness of TYGACIL for the proposed CAP indication. ‘.

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