Allergan gets FDA approval on three Mucinex-equivalent products

Allergan plc, Dublin, Ireland, and its partner Perrigo Company plc, also based in Dublin with U.S. headquarters in Allegan, Mich., announced that Allergan has received FDA approval on its Abbreviated New Drug Applications for three Mucinex-equivalent products:

• Mucinex DM Regular Strength (guaifenesin 600mg and dextromethorphan 30mg)
• Mucinex DM Maximum Strength (guaifenesin 1,200mg and dextromethorphan 60mg)
• Mucinex Maximum Strength (guaifenesin 1,200mg)

Perrigo will begin shipments of the products to its retail and wholesale customers in the United States in time for the 2016 cough and cold season, the companies said. These products will be packaged and marketed as store brands, which will give consumers high-quality value alternatives to these Mucinex extended-release products.

"The FDA approval of these products highlights Allergan's world-class generic R&D capabilities and underscores our commitment to continued innovation and focus on complex and high-barrier to entry products within our generics business," said Robert Stewart, Allergan's executive vice president and president, generics and global operations. "We are pleased that our partnership with Perrigo allows us to provide consumers with high-quality affordable options such as the Mucinex equivalent products."

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "These approvals are a significant milestone in the partnership between Perrigo and Allergan, and we are pleased to be the first company to bring these difficult to manufacture products to the market. This is another excellent example of Perrigo's commitment to making quality healthcare more affordable for consumers across the globe."