DUBLIN - Actavis and its partner Perrigo announced Tuesday that Actavis has received U.S. Food and Drug Administration approval for its abbreviated new drug application 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 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, according to the companies.
"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," stated Robert Stewart, EVP Actavis and president, generics and global operations.