"Approvable" letter for Salix' balsalazide

North Carolina, USA-based Salix Pharmaceuticals says it has received an "approvable" letter from the Food and Drug Administration for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

The firm received a communication from the FDA that its product is approvable, and Bill Forbes, vice president, R&D, 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."

Salix develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Its 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.