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Amoxicillin Pulsys NDA plans

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advancis anticipates a second-half 2005 NDA filing for its amoxicillin Pulsys formulation, using the firm's once-a-day pulsatile delivery technology. A Phase III trial in adolescents and adults with acute pharyngitis and/or tonsillitis due to Group A streptococcal infections began dosing Oct. 15, with results expected in the first half of 2005. GlaxoSmithKline terminated development of an Augmentin Pulsys formulation, effective Dec. 15. "Advancis remains confident that pulsatile amoxicillin/clavulanate is technically and commercially viable, and will be exploring other avenues and partners. Additionally, the company believes continued progress on its pulsatile version of amoxicillin will help support future productive Pulsys collaborations," Advancis says...

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