The US FDA’s approval of Mylan NV’s Wixela Inhub (fluticasone propionate/salmeterol) with patient instructions for use that are noticeably different from the reference product, GlaxoSmithKline PLC’s Advair Diskus, reflects the agency’s willingness to accept certain device design and labeling differences in the complex generics space.
The variation in instructions for use between Advair Diskus and Wixela Inhub stem from permissible design differences between the products’ user interfaces and are allowable under the “different manufacturers” exception to the “same labeling” requirement, FDA
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