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news.Actavis and Perrigo have secured approval from the US Food and Drug Administration for their abbreviated new drug application (ANDA) for guaifenesin/pseudoephedrine tablets.
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The tablets are an alternative to Mucinex D (Guaifenesin/pseudoephedrine tablets), an expectorant indicated to relieve chest congestion and make coughs more productive.
Perrigo will begin shipment of these tablets to supply them to wholesalers in the US in time for the cough/cold season. The product will be packaged and marketed under store and proprietary brands.
Actavis generics and global operations president and executive vice-president Robert Stewart said: "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 chairman and CEO Joseph Papa said: "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."