Hikma Pharmaceuticals announced that it has submitted its response to the FDA’s complete response letter regarding the company’s ANDA for a generic fluticasone propionate/salmeterol DPI. Hikma is partnered with Vectura on the DPI, a generic version of Advair Diskus known as VR315US.
The FDA issued the CRL in May 2017. In March 2018, Hikma announced that the agency had requested an additional clinical trial of the DPI. According to Hikma, data from the clinical endpoint study that was initiated in 2018 in response to that request have now been submitted.
Hikma CEO Siggi Olafsson commented, “Our team has worked extremely hard with Vectura to complete a large and challenging clinical study, which we believe demonstrates the safety and effectiveness of our product, and I am very pleased to have responded to the FDA. As we continue to develop our pipeline of complex generics, respiratory products are a key strategic focus for Hikma and our generic Advair submission is an important milestone. We are confident in our ability to bring a generic version of Advair to the US market, which would enable us to improve patient access to this important medicine.”
Vectura CEO Will Downie said, “Hikma’s submission is an important milestone in our generic Advair program. 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.”
Read the Hikma press release.
Read the Vectura press release.
