Perrigo Receives Final FDA Approval for Store Brand Equivalent to Generic Version of Mucinex


ALLEGAN — Perrigo Company (Nasdaq: PRGO; TASE) today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg. The new product will be packaged under store and proprietary brands that will compare to Mucinex® tablets. Perrigo is still in litigation with Reckitt Benckiser Group, PLC, the New Drug Application holder and patent owner of Mucinex®.

Mucinex® (Guaifenesin Extended-Release Tablets, 600 mg), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $146 million through food, drug and mass merchandisers for the last 12 months, as measured by Information Resources, Inc.

Perrigo’s Chairman and CEO Joseph C. Papa stated, “Our research and development group has worked diligently to achieve this accomplishment. 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.  This is another excellent example of Perrigo’s investment and commitment to making quality healthcare more affordable for our customers.” 

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (

SOURCE Perrigo Company