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Intrinsa withdrawn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Intrinsa withdrawn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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