Adams Mucinex Approval Spurs FDA Crackdown On Guaifenesin Products
This article was originally published in The Tan Sheet
Executive Summary
Unapproved, single-ingredient guaifenesin extended-release Rx products should no longer be marketed because there is now an approved OTC version, according to FDA
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FDA Maps Pathways To Compliance At Unapproved Drugs Workshop
FDA plans to increase enforcement actions against marketed unapproved drugs in the coming year, but hopes to cooperate with firms willing to come to the table seeking approval for currently unapproved products
FDA Maps Pathways To Compliance At Unapproved Drugs Workshop
FDA plans to increase enforcement actions against marketed unapproved drugs in the coming year, but hopes to cooperate with firms willing to come to the table seeking approval for currently unapproved products