Rx Guaifenesin Ban Justified By Compliance Policy Guide – Adams Labs
This article was originally published in The Tan Sheet
Executive Summary
FDA should notify federal agencies that Rx single-ingredient, extended-release guaifenesin drugs are no longer available for contract purchase, Mucinex marketer Adams Labs says in Nov. 22 comments
You may also be interested in...
FDA Guaifenesin Crackdown Based On Adams Labs NDA “Improper” – Petition
FDA's call for the immediate removal of unapproved guaifenesin extended-release drugs from the market "improperly cedes FDA's enforcement discretion to private parties," four law firms maintain in a Nov. 12 citizen petition
Adams Mucinex Approval Spurs FDA Crackdown On Guaifenesin Products
Unapproved, single-ingredient guaifenesin extended-release Rx products should no longer be marketed because there is now an approved OTC version, according to FDA
Adams Labs Mucinex Marketing Strategy Targeting Healthcare Professionals
Adams Laboratories plans to launch Mucinex "long-acting" guaifenesin tablets with a behind-the-counter sales strategy