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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Firm is looking for co-promotion partner for its oxybutynin transdermal patch, for which an NDA was submitted April 27. Watson expects the overactive bladder treatment to be approved in second quarter 2002. The company is reconsidering development of its Alnea (estradiol/progestin) patch. Watson received a "not approvable" letter in November citing "lack of sufficient evidence to support the safety and efficacy of the product for the prevention of hyperplasia." The firm submitted a supporting trial, but FDA found the trial underpowered and asked for an additional study. The company does not intend to conduct further trials and is considering whether to withdraw the NDA or pursue a hearing with FDA, Senior VP-R&D Chuck Ebert, PhD, said during a May 7 conference call. Watson plans to begin Phase III trials in 2001 with a once-daily oral estradiol/ progesterone product for hormone replacement therapy. An NDA filing is planned for late 2003

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