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ALLEGAN, Mich. — Perrigo Co. has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for guaifenesin extended-release tablets (600 mg), indicated for chest congestion.
The company said Monday that the new product is slated to launch next year and will be packaged under store brands and proprietary brands that will compare to Mucinex tablets.
Perrigo noted that it’s still in litigation with Reckitt Benckiser Group, the New Drug Application holder and patent owner of Mucinex, an expectorant designed to relieve chest congestion and make coughs more productive.
According to SymphonyIRI Group, Mucinex had sales of approximately $146 million through food, drug and mass retailers for the last 12 months.
"Our research and development group has worked diligently to achieve this accomplishment," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "Perrigo is working through the litigation and expects to begin shipping this product in our retail and wholesale customers’ store brand packaging in the second half of our fiscal year." The company’s fiscal 2012 second quarter ends in late December.
