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Solvay Preparing Announcement On Cilansetron NDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Solvay receives a response letter from FDA one week ahead of the user fee deadline for the irritable bowel syndrome product. Solvay is currently assessing the letter's contents, the company says.

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Solvay Cilansetron NDA "Not Approvable" For Irritable Bowel Syndrome

The "not approvable" letter requests additional clinical trials as well as changes to some non-clinical items, Solvay says. The company says it has informed FDA of its intent to amend the application.

Solvay Cilansetron NDA "Not Approvable" For Irritable Bowel Syndrome

The "not approvable" letter requests additional clinical trials as well as changes to some non-clinical items, Solvay says. The company says it has informed FDA of its intent to amend the application.

Solvay No Longer Expects Advisory Cmte. For Irritable Bowel Drug Calmactin

Additional information submitted by company for the IBS agent was too voluminous to be completely reviewed prior to joint committee meeting tentatively set for March, Solvay suggests. FDA action on cilansetron NDA is still expected by April 1.

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