FDA grants Perrigo final approval for Guaifenesin Extended-Release Tablets ANDA

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."  

SOURCE Perrigo Company