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Salix receives approvable letter for ulcerative colitis drug

Salix Pharmaceuticals has received an approvable letter from the FDA for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

Bill Forbes, vice president of R&D and chief development officer of Salix, said: “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.”