May 17, 2008 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has received an approvable letter from the U.S. Food and Drug Administration (FDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
"Late this afternoon Salix received a communication from the FDA that the Balsalazide Tablet NDA is approvable," stated Bill Forbes, Pharm.D., Vice President, Research and Development, and Chief Development Officer. "Salix will work diligently with the FDA over the next several days to compile a complete response to this approvable letter, which Salix believes will consist of referencing data already available."
The details can be read here.
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