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Tibolone Approval Status

Tibolone is a STEAR (Selective Tissue Estrogenic Activity Regulator) for the treatment of women with menopausal symptoms.

In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tibolone had not been approved.

Development Status and FDA Approval Process for Tibolone

Jun  2, 2006FDA Says Tibolone Not Approvable as a Menopause Treatment in the U.S.

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