Generic Advair's Labeling Variation Stems From Permissible Design Differences, US FDA Says

11 Feb 2019

Patient instructions for use of Mylan’s fluticasone/salmeterol generic are noticeably different from GSK’s reference listed drug but fall within the ‘different manufacturers’ exception to the ‘same labeling’ requirement.

Concept of absolute parity with two same size balls but different color in perfect balance on a balance.

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’...