VR315US: Hikma submits response to FDA
27th November 2019
Vectura Group notes today’s announcement by Hikma Pharmaceuticals, its partner in the development of an AB rated substitutable US generic version of Advair Diskus® (VR315US), that it has submitted responses to the US Food and Drug Administration (FDA) for review, which includes data from a further Clinical Endpoint study requested by the FDA in a Complete Response Letter (CRL).
Will Downie, Chief Executive Officer of Vectura, commented:
“Hikma’s submission is an important milestone in our generic Advair programme. We believe the submission addresses the outstanding questions raised by the FDA in its CRL and remain confident in the prospects for the approval of VR315US. We continue to see a large market opportunity for VR315US and look forward to working with Hikma to bring this product to the market as quickly as possible.”
The programme to develop an AB rated substitutable US generic version of Advair Diskus® uses our Lever-Operated Multi-Dose (LOMI) device.
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