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Banner laxative petition denied

This article was originally published in The Tan Sheet

Executive Summary

Data presented by Banner Pharmacaps fails to show docusate calcium can be interchanged with docusate sodium, FDA says in a Nov. 17 letter. The firm asked in a 2002 petition that the two ingredients be considered interchangeable in OTC laxative drug product monograph combinations. (1"The Tan Sheet" June 24, 2002, In Brief). The agency says data are needed showing the bioavailability of docusate calcium relative to docusate sodium "is not affected when combined with sennosides A and B or sodium carboxymethylcellulose." The letter recommends firm contact the agency's OTC division before commencing new studies...
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