Salix Pharmaceuticals, Ltd. has announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
Based on its review, the FDA has determined that the application cannot be approved in its present form and that clinical data from an additional adequate and well-controlled clinical trial will be required in order to conduct further review on the NDA.
Salix believes its balsalazide tablet NDA, including its June 30, 2008 complete response to the FDA's May 16, 2008 approvable letter, is sufficient for approval. The Company does not agree with the Agency's determination and will be requesting a Type A meeting with the Director of the Division of Gastroenterology Products, Center for Drug Evaluation and Research (CDER) to discuss the Agency's complete response letter. FDA procedures allow for a Type A meeting to occur within 30 days of FDA's receipt of a written meeting request from the NDA sponsor.
The Company does not intend to conduct additional clinical investigation of balsalazide tablet in this indication. However, the Company is committed to meeting with and working with the FDA to determine if the issues described in the December 22, 2008 complete response can be resolved and the product can be approved for marketing.