FDA rejects Salix's ulcerative colitis drug

The FDA has decided that Salix Pharmaceuticals will have to run another "adequate and well-controlled clinical trial" before it can approve the company's ulcerative colitis tablet balsalazide. The company is none too pleased with this decision, saying that its NDA for balsalazide was sufficient for approval. Salix "does not intend to conduct additional clinical investigation of balsalazide tablet in this indication," though the company will request a meeting with the FDA to discuss the negative ruling, according to a statement. Salix's stock fell 5 percent following the decision.

- here's Salix's release
- read this AP report

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