Tibolone FDA 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 timeline for Tibolone
|Jun 2, 2006||FDA Says Tibolone Not Approvable as a Menopause Treatment in the U.S.|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.