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FDA approves Abbreviated NDAs for Mucinex equivalent products

11 September 2015  •  Author: Victoria White

Allergan and its partner Perrigo have received US Food and Drug Administration (FDA) approval for Abbreviated New Drug Applications for three Mucinex equivalent products.

mucinex

The products in question are:

  • Mucinex DM Regular Strength (guaifenesin 600mg and dextromethorphan 30mg)
  • Mucinex DM Maximum Strength (guaifenesin 1200mg and dextromethorphan 60mg)
  • Mucinex Maximum Strength (guaifenesin 1200mg)

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

Mucinex Maximum Strength is an expectorant indicated to relieve chest congestion and thin and loosen mucus. Sales for the last twelve months were $73 million. 

Mucinex DM Regular and Maximum Strengths are expectorants indicated to control coughs and thin and loosen mucus. Mucinex DM Regular and Maximum Strengths sales for the last twelve months were $67 million and $104 million, respectively.

Robert Stewart, Allergan’s Executive Vice President & President, Generics and Global Operations, stated, “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. 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.”  

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