FDA responds to Salix regarding denied approval for ulcerative colitis treatment

RALEIGH, N.C. The Food and Drug Administration has delivered a complete response letter to Salix Pharmaceuticals for its approval application for an ulcerative colitis treatment, Salix announced last week.

The company said the FDA would not approve balsalazide tablets in their present form, and it will require clinical data from an “additional adequate and well-controlled clinical trial.”

Salix said its application for the tablets, including its June 30 complete response to the FDA’s May 16 approvable letter, are sufficient for approval.

In response to the agency’s complete response letter, it will request a meeting with the director of the FDA Center for Drug Evaluation and Research’s Division of Gastroenterology Products, Donna Griebel.