Calmactin
cilansetron
Treatment for Irritable Bowel SyndromeFDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
MARIETTA, Ga., April 01, 2005 -- As announced last week during a corporate press conference in Brussels, Solvay Pharmaceuticals, Inc. has received a letter from the Food and Drug Administration (FDA) on its new drug application (NDA) for cilansetron, a novel drug submitted to the Agency for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D) in both men and women. The "not-approvable" action letter requests additional clinical trials. Solvay Pharmaceuticals, Inc. is examining its options and will discuss future steps with the FDA and other experts for this product in the U.S.
About IBS-D
As many as 30-45 million North American adults have symptoms of IBS
-- approximately one-third from IBS-D. The common symptoms of IBS-D
are diarrhea, abdominal pain/discomfort, and fecal urgency. IBS has
a significant negative impact on the quality of life for the many
men and women who suffer from this condition, causing lost days of
work and interfering with home- based, social and leisure
activities.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia (USA), is a
research-driven pharmaceutical company that seeks to fulfill unmet
medical needs in the therapeutic areas of cardiology,
gastroenterology, mental health, women's health and a select group
of specialized markets including men's health. It is a part of the
global Solvay Pharmaceuticals organization whose core activities
consist of discovering, developing and manufacturing medicines for
human use. Solvay Pharmaceuticals, Inc. is a subsidiary corporation
of the worldwide Solvay Group of chemical and pharmaceutical
companies headquartered in Brussels, Belgium.
For more information, please visit www.solvaypharmaceuticals-us.com
Related Articles:
Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue - November 29, 2005
Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance - September 1, 2004
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