Table of Contents
DUBLIN, Ireland — Actavis plc and Perrigo Co. plc have been cleared by the Food and Drug Administration to market guaifenesin/pseudoephedrine tablets, an expectorant.
Actavis plc and Perrigo Co. plc have been cleared by the Food and Drug Administration to market guaifenesin/pseudoephedrine tablets, an expectorant.
The companies said that Perrigo is slated to commence shipments to U.S. retail and wholesale customers in time for the cough/cold season. The product will be packaged and marketed under store and proprietary brands and be a high-quality, value alternative to Reckitt Benckiser’s Mucinex D tablets.
"We are pleased to partner with Perrigo to provide consumers with this high-quality, affordable treatment option," stated Robert Stewart, executive vice president and president of generics and global operations at Actavis. "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."
Mucinex D tablets (guaifenesin/pseudoephedrine) are indicated to relieve chest congestion and make coughs more productive. The medication had U.S. sales of about $83 million through food, drug and mass merchandisers over the last 12 months, Actavis and Perrigo reported.
"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," commented Perrigo chairman and chief executive officer Joseph Papa. "This is another excellent example of Perrigo’s commitment to making quality health care more affordable for our customers."