FDAnews Drug Daily Bulletin

FDA: ORGANON'S MENOPAUSE DRUG 'NOT APPROVABLE'

June 14, 2006
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Organon will withdraw its new drug application for tibolone after receiving notice from the FDA that it is "not approvable," the company announced.

In the announcement, the company said that it will remain committed to tibolone, a synthetic steroid designed for women with menopausal symptoms. The drug has been approved and marketed in other countries for more than 20 years, the company said.

Organon, the human healthcare division of Akzo Nobel, did not release any details of the FDA's decision.