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Cubist Pharma Issues ENTEREG Supplemental NDA

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Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

This proposed label modification is derived from a recently completed randomized, double-blind, placebo-controlled, Phase 4 clinical trial of patients undergoing radical cystectomy for bladder cancer, an extensive surgical procedure that includes resecting a segment of bowel to reconstruct the lower urinary tract. This study, in conjunction with the original clinical trial data, forms the body of evidence supporting the request for expansion of the current indication.

Posted-In: News FDA

 

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