COLAZAL(R) Pediatric Exclusivity Granted.RALEIGH, N.C. -- Salix Pharmaceuticals, Ltd. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SLXP) today announced that the U.S. Food and Drug Administration has granted COLAZAL(R) additional marketing exclusivity through January 8, 2007. The exclusivity is based upon the FDA's acceptance of the clinical package the Company submitted on June 20, 2006 in response to a Written Request received from the U.S. Food and Drug Administration for clinical information about the safe and effective use of COLAZAL in pediatric patients between 5 and 17 years of age with ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has informed Salix that the new marketing exclusivity expiration date Expiration Date The day on which an options or futures contract is no longer valid and, therefore, ceases to exist. Notes: The expiration date for all listed stock options in the U.S. for COLAZAL will be posted in the Electronic Orange Book (EOB EOB Explanation Of Benefits EOB End Of Block EOB Eye of the Beholder (game) EOB Executive Office Building (next to White House) EOB Electronic Order of Battle EOB Electricity Oversight Board ) at the EOB's next update. Historically, the EOB has been updated on a monthly basis. COLAZAL(R) (balsalazide disodium balsalazide disodium Colazide (UK), Colazal Pharmacologic class: GI agent Therapeutic class: Anti-inflammatory Pregnancy risk category B Action) Capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studies. In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia arthralgia /ar·thral·gia/ (ahr-thral´jah) pain in a joint.ar·thral·gia n. Severe pain in a joint. Also called arthrodynia. (4%). Withdrawal from therapy due to adverse events was comparable to placebo. Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina For other uses of this name, see Raleigh. Raleigh (IPA: /ˈrɑli/, ral-ee) is the capital of the State of North Carolina and the county seat of Wake County. , develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company's gastroenterology specialty sales and marketing team. Salix also markets XIFAXAN(R), VISICOL(R), OSMOPREP(TM), AZASAN(R), ANUSOL-HC(R) and PROCTOCORT(R). In August 2006, the FDA approved MOVIPREP(R) for bowel cleansing prior to colonoscopy, and we intend to launch sales of the product in mid-fourth quarter 2006. Granulated gran·u·late v. gran·u·lat·ed, gran·u·lat·ing, gran·u·lates v.tr. 1. To form into grains or granules. 2. To make rough and grainy. v.intr. mesalamine is under development. Salix trades on the NASDAQ Global Market under the ticker symbol "SLXP". For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings. Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks of potential generic and other competition, regulatory review and clinical trials, market acceptance for approved products, intellectual property risks, the need to acquire additional products, and management of rapid growth. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion