FDA approval for guaifenesin generics

Genéricos/Novedades | Posted 02/10/2015 post-comment0 Post your comment

Allergan (formerly Actavis) and its partner Perrigo Company (Perrigo) announced on 10 September 2015 that the companies had received US Food and Drug Administration (FDA) approval for their abbreviated new drug applications for three guaifenesin generics.

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The products are generic versions of Reckitt Benckisser’s cold and flu medicine Mucinex (guaifenesin) and are equivalent to the following products:

  • Mucinex DM Regular Strength (guaifenesin 600 mg/dextromethorphan 30 mg)
  • Mucinex DM Maximum Strength (guaifenesin 1200 mg/dextromethorphan 60 mg)
  • Mucinex Maximum Strength (guaifenesin 1,200 mg)

Mucinex Maximum Strength is an expectorant indicated to relieve chest congestion and thin and loosen mucus. Mucinex DM Regular and Maximum Strengths are expectorants indicated to control coughs and thin and loosen mucus. Mucinex Maximum Strength, Mucinex DM Regular and Mucinex DM Maximum Strengths sales for the last twelve months were US$73 million, US$67 million and US$104 million, respectively.

Perrigo is expected to begin shipments of the products to its retail and wholesale customers in the US in time for the 2016 cough and cold season.

Related article
Generics companies sue Reckitt Benckisser over generics supplies

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Source: Allergan

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