P&G withdraws Intrinsa NDA

Procter & Gamble withdraws NDA for female testosterone patch Intrinsa, but plans to resubmit the application for the hypoactive sexual desire disorder treatment with additional data from trials in naturally menopausal women. The trials are "nearly complete," the company said. At its Dec. 2 meeting, the Reproductive Health Drugs Advisory Committee agreed that additional safety data is needed because of the potential for broad off-label use (1"The Pink Sheet" Dec. 6, 2004, p. 18). The company was seeking an indication for use in surgically menopausal women...

Procter & Gamble withdraws NDA for female testosterone patch Intrinsa , but plans to resubmit the application for the hypoactive sexual desire disorder treatment with additional data from trials in naturally menopausal women. The trials are "nearly complete," the company said. At its Dec. 2 meeting, the Reproductive Health Drugs Advisory Committee agreed that additional safety data is needed because of the potential for broad off-label use (¹ (Also see "Intrinsa Needs More Safety Studies In Face Of Potential Off-Label Use" - Pink Sheet, 6 Dec, 2004.), p. 18). The company was seeking an indication for use in surgically menopausal women....