Salix receives FDA approvable letter for Balsalazide colitis treatment

RALEIGH, N.C. Salix Pharmaceuticals has received an approvable letter from the Food and Drug Administration for its ulcerative colitis drug Balsalazide Tablet NDA, the company announced May 16. The drug is designed to treat mild-to-moderate active ulcerative colitis in patients 18 years and older. The disease causes ulcers in the lining of the rectum and colon.

Salix has headquarters in Raleigh, N.C., and specializes in drugs to treat gastrointestinal disorders. The company markets such drugs as Colazal (balsalazide disodium) capsules 750 mg, Xifaxan (rifaximin) tablets 200 mg, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets and Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution.