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Advair Bioequivalence Guidance Falls Short of GSK’s Requests

 
• By Sarah Karlin-Smith

FDA’s draft guidance requires clinical study but sets a lower bar to generics of GSK’s blockbuster asthma and COPD treatment than company proposed; standards appear poised for warm reception from generic challengers.

GlaxoSmithKline PLC got only a fraction of its requests granted in FDA’s newly published draft guidance outlining recommendations for ANDA sponsors seeking to market copies of the company’s mega-seller Advair Diskus (fluticasone/salmeterol), leaving generic manufacturers with an easier path to approval than the company desired.

And the draft bioequivalence guidelines, slated to be announced in the Sept. 10 Federal Register, will now compete for attention with other news GSK may have...

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More from United States

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
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More from North America

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• By Lauren Flynn Kelly

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US FDA Meeting Drought Ends … With A Vengeance

 
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PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.