Salix gets balsalazide complete response

Salix (NASDAQ:SLXP) received a complete response letter from FDA for an NDA for balsalazide tablets to treat mild to moderate active ulcerative colitis in adult patients. Salix said FDA requested an additional clinical trial, but that the company does not intend to conduct one. The company, which said it believes its NDA and complete response to a May 16 approvable letter is sufficient for approval, plans to request a meeting with FDA. The company also said the agency did not request the additional trial in the May approvable letter. ...