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The US FDA rejects Vectura and Hikma Pharmaceuticals' VR315.

M2 PHARMA-May 15, 2017-The US FDA rejects Vectura and Hikma Pharmaceuticals' VR315


The US Food and Drug Administration (FDA) has rejected United Kingdom-based Vectura and its partner Hikma Pharmaceuticals' VR315, a generic version of GlaxoSmithKline's asthma/COPD inhaler, Advair Diskus, it was reported on Friday.

Hikma has received a complete response letter from the FDA on the abbreviated new drug application.

According to Vectura, the US FDA has categorised the complete response letter as major, and no material issues were raised regarding the substitutability of the proposed device based on the initial assessment. After completing the review and discussions with the US Food and Drug Administration, both firms will provide an update on its application of the generic asthma treatment. Vectura also stated that the VR315 programme is expected to receive approval in 2017, based on the nature of the feedback. In addition, the companies are not expecting to receive an approval milestone or sales royalties for VR315 in 2017.

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Publication:M2 Pharma
Date:May 15, 2017
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