ARNHEM/OSS, The Netherlands, April 11, 2002 (PRIMEZONE) -- Akzo Nobel's (Nasdaq:AKZOY) business unit Organon has received a letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for marketing authorization of gepirone ER tablets (also known as Ariza). The letter mentions issues that will have to be addressed before the product can be approved. Organon has already contacted the FDA about providing additional information or clarification as necessary.
Organon has confidence in the NDA it submitted in May 2001, and trusts in its ability to satisfactorily address the issues presented in the letter. However, approval of the product is dependent upon the outcome of consultation with the FDA. It is not possible to provide more information with regard to marketing authorization until after receipt of further response from the FDA. It is expected, however, that contrary to previous announcements the product will not be introduced in 2002.
Ariza is a new drug for the treatment of patients with major depressive disorders.
Note for the Editor
Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2001 totaled EUR 14 billion. The Company currently employs approximately 66,000 people in 80 countries. Financial results for the first quarter will be published on April 23, 2002.
Organon is a renowned global pharmaceutical company with a strong commitment to healthcare. The company develops and produces innovative prescription medicines for gynecology, psychiatry, cardiovascular disease, immunology and anesthesiology.
Organon products are sold in over 100 countries, more than half of which have an Organon subsidiary. The company currently employs around 13,000 people. NV Organon is the ethical pharmaceutical business unit of Akzo Nobel.
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