Congestion Continues In Private Label Mucinex Pipeline; Court Rules Against Mutual
This article was originally published in The Tan Sheet
A ruling for RB n Pennsylvania federal court comes as it girds for increased competition from additional guaifenesin expectorant formulations that are the equivalents of Mucinex brand products and that Perrigo is marketing under license from manufacturer Allergan.
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Mutual Pharmaceutical alleges in an antitrust suit that RB attempts to monopolize the extended-release guaifenesin OTC category with its Mucinex product. The suit says Mutual has lost “tens of millions” due to RB's failure to honor a contract to supply an “authorized generic” of the product.
“Something needed to be done” to improve FDA’s regulation of human foods supply, says Commissioner Califf says. “Dietary supplements is a whole different kettle of fish that we can discuss at a later time.”
Following reviews prompted largely by formula supply crisis, FDA will move Center for Food Safety and Applied Nutrition and commissioner’s Office of Food Programs and Response to Human Foods Program headed by deputy commissioner. Office of Regulatory Affairs' structure also changing “to support the FDA organization as a whole,” says Commissioner Califf.