Mylan’s Generic Advair Approval Showcases US FDA Efforts To Boost Complex Products

Commissioner Gottlieb previews actions agency intends to take in 2019 to smooth the regulatory and scientific pathway for generics of complex drugs, including draft guidance with recommendations on establishing active ingredient sameness.

Mylan NVbecame the highest profile industry beneficiary of the US FDA’s push to bring more complex generics to market with the agency’s Jan. 30 approval Wixela Inhub, the first generic version of GlaxoSmithKline PLC’s hard-to-copy Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

Mylan gained FDA approval for three strengths of the inhaled treatment for asthma and chronic obstructive pulmonary disease: fluticasone propionate

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