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Vivus/KV EvaMist approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves Vivus' metered-dose topical estradiol spray EvaMist to treat moderate to severe vasomotor symptoms due to menopause. The July 27 approval triggers a $140 million payment to Vivus from KV Pharmaceutical, which will market the drug with its more than 280-strong sales force. Vivus received a $10 million up-front payment and is eligible to get more money based on sales milestones. The firm is touting EvaMist's safety profile, but will be competing in a crowded transdermal estradiol market with close competitors Esprit Pharma's Estrasorb, Ascend's EstroGel and BioSante's Elestrin. Vivus is also developing an obesity combo agent, Qnexa (1Pharmaceutical Approvals Monthly September 2006, p. 11)...

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