Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar

As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.

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The FDA Office of Generic Drugs does not want differences between complex generics and their reference products to hinder generic uptake. • Source: Shutterstock

The US Food and Drug Administration sees proactive surveillance of complex generics as a chance to avoid patient rejection of first generics in addition to monitor for any potential safety problems.

Among the first test cases is the launch of Mylan NV’s Wixela Inhub (fluticasone propionate/salmeterol), the first generic of...

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