Columbia/Wyeth Crinone vaginal progesterone NDA to be filed in June for amenorrhea, Columbia says.
COLUMBIA/WYETH CRINONE SEVERE AMENORRHEA NDA FILING PLANNED FOR JUNE, Columbia Labs said following April 25 release of Phase III trial results for the natural progesterone vaginal product. Crinone will be marketed worldwide by Premarin and Prempro/Premphase manufacturer Wyeth-Ayerst. In the studies, 80% of women treated with either 45 mg or 90 mg of the Crinone resumed menstruation. Biopsies confirmed endometrial activity of the drug in 94% of women receiving 45 mg and in 100% of those receiving 90 mg.
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