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FDA issues product-specific draft guidances for four more inhalation products

The US FDA has issued four new product-specific draft guidances in April 2016 for inhalation products, including three dry powder products and one MDI. The documents include recommendations on establishing bioequivalence for generic versions of Breo/Relvar Ellipta, Arnuity Ellipta, Arcapta Neohaler/Onbreez Breezhaler, and Asmanex HFA,

Read the new guidances for the following products:

Fluticasone furoate/Vilanterol trifenatate

Fluticasone furoate monotherapy

Indacaterol maleate

Mometasone furoate

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published on April 25, 2016

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