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P&G’s Intrinsa Priority Review Puts Approval Timeline At Early 2005

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Procter & Gamble’s testosterone patch Intrinsa could be approved for female sexual dysfunction by January.

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Intrinsa withdrawn

P&G plans to re-submit its female sexual disorder treatment Intrinsa with data from trials in naturally menopausal women. The testosterone patch had been submitted for use in surgically menopausal women (1Pharmaceutical Approvals Monthly Oct. 1, 2004, p. 25). FDA's Reproductive Health Drugs Advisory Committee recommended against approval Dec. 2, citing potential for off-label use in a broader population and requesting more safety data. The additional trials are "nearly complete," P&G says...

Intrinsa withdrawn

P&G plans to re-submit its female sexual disorder treatment Intrinsa with data from trials in naturally menopausal women. The testosterone patch had been submitted for use in surgically menopausal women (1Pharmaceutical Approvals Monthly Oct. 1, 2004, p. 25). FDA's Reproductive Health Drugs Advisory Committee recommended against approval Dec. 2, citing potential for off-label use in a broader population and requesting more safety data. The additional trials are "nearly complete," P&G says...

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Vivus initiates Phase III trial of its topical alprostadil Alista for treatment of female sexual arousal disorder, the firm announces Sept. 7. Alprostadil, a synthetic prostaglandin, is the same active ingredient found in the company's male erectile dysfunction product Muse. Vivus expects two to four trials in 1,500-2,000 patients will support the Alista NDA, which will be submitted in late 2006 or in 2007 (1Pharmaceutical Approvals Monthly July 1, 2004, p. 24). The firm also has a testosterone spray slated to enter Phase III in 2005...

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