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

 
• By Sue Sutter

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’...

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Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

More from Biosimilars & Generics

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

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‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.