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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.

Hikma and Vectura said they will provide an update on the application as soon as practicable after reviewing the CRL and discussing the contents with FDA. They noted there did not appear to be any material issues related to the substitutability of the proposed device

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