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news.The FDA has determined that Dutch chemicals company Akzo Nobel's new drug application for tibolone for the treatment of menopausal symptoms is 'not approvable.'
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As a result, Akzo Nobel has decided not to launch the drug in the US and has accordingly withdrawn its application with the FDA.
The decision by the FDA is surprising as the drug has been approved and marked in countries outside the US for nearly 20 years. The agency’s response follows an amendment to the new drug application (NDA) Akzo Nobel’s healthcare subsidiary Organon filed with the FDA in December 2005.
“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.