Chippenham, UK-based Vectura and its partner Hikma Pharmaceuticals have announced a major setback in the US after VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus, was rejected by the FDA.
The US Food and Drug Administration issued a Complete Response Letter in relation to the abbreviated new drug application for the product.
The content of the Letter not been revealed, only that it was classed as “Major” and that no material issues were raised regarding the substitutability of the proposed device.
Hikma and Vectura said they will provide an update on its application “as soon as practicable” once a review of the CRL and subsequent discussions with the US Food and Drug Administration are complete.
The firms also noted that the remain “committed to bringing this important product to the US market and have confidence in the future approval of the programme”, but given the nature of the feedback “there is a low likelihood of approval of the VR315 programme this year”.