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Article: Joint Advisory Panel to the FDA Recommends Action on Lotronex(R) For Irritable Bowel Syndrome.
- Article from:
- PR Newswire
- Article date:
- April 23, 2002
CopyrightCOPYRIGHT 2002 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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RESEARCH TRIANGLE PARK, N.C. -- A joint advisory panel to the U.S. Food and Drug Administration (FDA) reviewed the elements of a supplemental New Drug Application (sNDA) submitted by GlaxoSmithKline (GSK) for Lotronex (alosetron HCl) in the treatment of women with diarrhea- predominant irritable bowel syndrome. The panel recommended that the FDA consider the possible reintroduction of the drug to the market under restrictions to be determined in discussions between the FDA and the company.
Panel members from the Gastrointestinal Drugs Advisory Committee and the newly formed Drug Safety and Risk Management Subcommittee of the Pharmaceutical Science Committee ...