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Tibolone Approval Status

FDA Approved: No
Generic name: Tibolone
Company: Organon Pharmaceuticals
Treatment for: Perimenopausal Symptoms

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

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

Further information

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