Organon's gepirone rejected in the USA
Dutch pharmaceutical company, Organon, a division of Akzo Nobel, saysthat the US Food and Drug Administration has determined that its New Drug Application for the antidepressant gepirone ER is not approvable.
The amended NDA was submitted by Organon in December 2003, and the firm now plans to withdraw its application for gepirone as a treatment for major depressive disorder, following the FDA's decision. "Organon is disappointed in this response from the FDA and we are moving forward with our next steps in the development of products for mental health," commented Toon Wilderbeek, Organon's international president.
The product was to replace the company's flagship antidepressant Remeron (mirtazapine), which has faced increasing generic competition since losing its US patent protection in 2002. This is further bad news for Akzo's Organon unit, which reported a 7% drop in pharmaceutical sales in the first quarter of this year (Marketletter April 26).
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