Hikma statement on generic Advair Diskus
Company been able to clarify and resolve a number of the questions raised by the FDA.
Vectura confirms the statement made by its partner Hikma Pharmaceuticals in its interim results statement in respect of its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus (VR315).
"We announced on 11 May 2017 that the FDA had issued a complete response letter (CRL) in relation to our abbreviated new drug application (ANDA) for our generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Since then we, supported by our partner Vectura, have had constructive discussions with the FDA and have been able to clarify and resolve a number of the questions raised. The discussions with the FDA have confirmed the initial assessment that there are no material issues regarding the substitutability of the proposed device.
We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so."
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