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
| Date | Article |
|---|---|
| Jun 2, 2006 | FDA Says Tibolone Not Approvable as a Menopause Treatment in the U.S. |
Further information
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