Sepracor cuts Soltara
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Sepracor discontinues development of its antihistamine Soltara (tecastemizole, formerly norastemizole) for allergic rhinitis "after taking into consideration the results from recent tecastemizole trials [and] evaluating the changing dynamics of the U.S. antihistamine market," Sepracor reports Dec. 2. Soltara was found "not approvable" March 6, 2002 due to concerns about its QT profile (1Pharmaceutical Approvals Monthly March 1, 2002, In Brief). Sepracor said it initiated "several preclinical and clinical studies" after meeting with FDA in late 2002, but "results from some of these…trials indicate that the company would need to conduct additional studies." Soltara is the active metabolite of Janssen's Hismanal (astemizole), withdrawn from the market in June 2001 because of cardiac side effects...
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