Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Salix Pharmaceuticals has received a complete response letter from the FDA for its new drug application for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
Subscribe to our email newsletter
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 new drug application (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 is expected to be requesting a Type A meeting with the director of the division of gastroenterology products, Center for Drug Evaluation and Research, to discuss the agency’s complete response letter. The FDA procedures allow for a Type A meeting to occur within 30 days of the 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 complete response can be resolved and the product can be approved for marketing.