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Will Salix contest FDA action letter for Colazal follow-on?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Salix will request a Type A meeting including FDA's gastroenterology division director, Donna Griebel, to discuss a Dec. 22 "complete response" letter for the tablet formulation of its ulcerative colitis drug Colazal (balsalazide), the firm says Dec. 29. The action letter is the second for the new 1.1 mg tablet formulation of the 5-ASA prodrug, which was approved as a 750 mg capsule in 2000. FDA said the NDA cannot be approved in its present form, and requires clinical data from an adequate and well-controlled trial. Salix, however, declared that it "does not intend to conduct additional clinical investigation" in the indication and believes the NDA is sufficient for approval based on the firm's June 30, 2008, response to the "approvable" letter issued by FDA a month earlier, on May 16. The balzalazide tablet formulation would allow a less frequent dosing regimen of 3.3. g twice daily for mild to moderate acute ulcerative colitis
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