FDA says tibolone not approvable as a menopause treatment in the U.S.
Arnhem, the Netherlands, June 2, 2006 —The U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) submitted for tibolone by Akzo Nobel’s human healthcare business, Organon, is “not approvable”.
This response follows an amendment to the NDA which Organon filed with the FDA in December 2005. Organon plans to withdraw the application for tibolone as a treatment for women in the United States with menopausal symptoms. “Although Organon is disappointed with the FDA’s response, we will continue to be committed to this proven brand,” said Toon Wilderbeek, General Manager of Organon and member of Akzo Nobel’s Board of Management responsible for Pharma. “Tibolone is available all over the world in countries outside the U.S. where it has been approved and marketed for nearly 20 years.” ---