Posted by jrbecker on June 25, 2004, at 8:16:51
oh well...
June 24, 2004 07:53 PM US Eastern Timezone
FDA Finds Gepirone ER 'Not Approvable' as a Treatment for Major Depressive Disorder
ARNHEM, Netherlands--(BUSINESS WIRE)--June 24, 2004--The U.S. Food and Drug Administration has determined that Organon's gepirone ER New Drug Application is "not approvable."
This action is the FDA's response to an amendment to Organon's New Drug Application submitted to the FDA in December 2003. Organon plans to withdraw the application for gepirone as a treatment for major depressive disorder."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," said Toon Wilderbeek, Organon International President and Akzo Nobel Board Member.
Note for the editor
Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2003 totaled EUR 13 billion. The Company currently employs approximately 64,300 people in more than 80 countries. Financial results for the second quarter will be published on July 19, 2004.
Organon, headquartered in Roseland, NJ, USA creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary.
Organon is the human health care business unit of Akzo Nobel.
Internet: www.akzonobel.com; www.organon.com
Not for publication - for more information
Organon Pharmaceuticals USA Inc. - Fran DeSena, Phone +1 973 325 5353
Safe Harbor Statement*
This press release may contain statements which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission. A copy of which can be found on the Company's website.
-- Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
poster:jrbecker
thread:360155
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