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Hikma's CRL Proves GSK's Witty Was Right: Generic Advair Is Hard

 
• By Jessica Merrill

FDA issued a complete response letter for Hikma's ANDA to market a generic version of GSK's Advair, the second application to be rejected by FDA.

Hikma Pharmaceuticals PLC's ANDA for a generic version of GlaxoSmithKline PLC's Advair Diskus (salmeterol/fluticasone) received a complete response letter from FDA that was designated "major," just like a rival drug from Mylan NV. The announcement May 11 by Hikma's development partner Vectura Group PLC on VR315 makes the launch of an interchangeable generic in 2017 highly improbable.

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