FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

Jun 2 2015

Actavis plc (NYSE: ACT) and its partner Perrigo Company plc (NYSE: PRGO; TASE) announced today that Actavis has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application (ANDA) for guaifenesin/pseudoephedrine tablets and that Perrigo will begin shipments in time for the cough/cold season to its retail and wholesale customers in the U.S. The product will be packaged and marketed under store and proprietary brands and will be a high quality, value alternative to Mucinex® D tablets.

Mucinex® D (Guaifenesin/pseudoephedrine tablets), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $83 million through food, drug and mass merchandisers over the last 12 months.

Robert Stewart, Executive Vice President Actavis, and President, Generics and Global Operations stated, "We are pleased to partner with Perrigo to provide consumers with this high-quality, affordable treatment option. The FDA's approval of this complex product highlights the strength of Actavis' world-class generic R&D capabilities and underscores our commitment to continued innovation within our generics business."

Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is representative of the great partnership between Perrigo and Actavis, working together to get this difficult to manufacture and high priced product to the market. This is another excellent example of Perrigo's commitment to making quality healthcare more affordable for our customers."