Printer Friendly

FDA ADVISORY COMMITTEE RECOMMENDS LUVOX (FLUVOXAMINE) TABLETS FOR OBSESSIVE COMPULSIVE DISORDER

 ROCKVILLE, Md., Oct. 18 /PRNewswire/ -- The U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drug Products Advisory Committee today unanimously recommended approval of LUVOX (fluvoxamine) Tablets(TM) for the treatment of Obsessive Compulsive Disorder (OCD). The advisory committee made its recommendation after hearing the results of clinical trials conducted in the United States, Canada and Europe, involving more than 28,000 patients worldwide over a period of 17 years, according to Solvay Pharmaceuticals, developers and marketers of LUVOX.
 The committee agreed that the data presented demonstrated the safety and efficacy of LUVOX, which is a potent selective serotonin reuptake inhibitor (SSRI), for the treatment of OCD. Although recommendations of advisory committees are not binding on the FDA, the agency typically takes them into account as the final decision is made.
 "We are very encouraged by the outcome of this meeting," said Laurence J. Downey, M.D., senior vice president of Solvay Pharmaceuticals' sales and marketing division. "Luvox has been shown to effectively reduce the symptoms of OCD, with fewer side effects than current available drug therapy. We believe LUVOX has distinct benefits, and we look forward to working with The Upjohn Company (NYSE: UPJ) to make this drug available to the millions of people in the United States who suffer from OCD."
 Solvay Pharmaceuticals of Marietta, Ga., is a research-based pharmaceutical company active in the therapeutic areas of women's health gastroenterology and mental health. Solvay Pharmaceuticals is a member of the Solvay S.A. group of companies.
 Solvay S.A. is a worldwide chemical and pharmaceutical company with annual sales in excess of $8 billion. Headquartered in Brussels, Belgium, Solvay S.A. has an emerging health sector, worth more than $1 billion in sales, with a special interest in mental health disorder therapies.
 Fluvoxamine, a product of Solvay S.A.'s health division research, originated in the Solvay Duphar Laboratories in the Netherlands. It is currently available for the treatment of depression in 36 countries and has been prescribed to more than 4.5 million patients worldwide. Regulatory approvals are being sought for depression and other indications in other major countries in addition to the United States.
 It is estimated that four to six million Americans have OCD, yet only 5 percent are receiving treatment, according to the Obsessive Compulsive Foundation, a national non-profit organization dedicated to expanding research, understanding and treatment of OCD. OCD affects the central nervous system and is characterized by recurring, uncontrollable thoughts (obsessions) and meaningless, ritualistic behaviors (compulsions), like washing, checking, counting, hoarding and arranging.
 Solvay Pharmaceuticals and Upjohn announced in May 1991 that they had entered into a strategic alliance in which Upjohn will jointly market Fluvoxamine in the United States, Europe and other areas throughout the world. That agreement also gave Solvay Pharmaceuticals the rights to jointly market Upjohn's anti-anxiety treatment, Xanax.
 The Upjohn Company is a worldwide, research-based provider of human health care products, animal health products, agronomic and vegetable seeds and specialty chemicals.
 -0- 10/18/93
 /CONTACT: Keith Morris of Solvay Pharmaceuticals, 404-578-5503, or Laurie McGrane of Ketchum Public Relations, 212-536-8744/
 (UPJ)


CO: Solvay Pharmaceuticals; Upjohn Company ST: Georgia, Michigan IN: MTC SU: PDT

LG-SM -- NY005 -- 3430 10/18/93 13:26 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Oct 18, 1993
Words:533
Previous Article:McDONNELL DOUGLAS JETS CERTIFIED FOR OPERATION IN THE COMMONWEALTH OF INDEPENDENT STATES
Next Article:INHILCO TERMINATES CURRENT MANAGEMENT CONTRACT WITH WINDOWS ON THE WORLD; WILL ACTIVELY PURSUE NEW CONTRACT
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters