One day after the FDA announced that it has approved Mylan’s ANDA for Wixela Inhub, a generic version of Advair Diskus fluticasone propionate/salmeterol DPI, Mylan has announced that it will launch the product by the end of February. The FDA approved Wixela Inhub in three strengths for the treatment of COPD and for the treatment of asthma in patients aged 4 years and older.
Mylan CEO Heather Bresch said, “Mylan remains steadfast in its efforts to expand patient access to medicines, and the FDA approval of Wixela Inhub reinforces our commitment to provide patients greater choice and lower-cost alternatives. This milestone represents the culmination of an extensive research and development program and Mylan’s more than $700 million of investment. We’re proud of our Wixela Inhub team, who worked tirelessly and in close collaboration with the FDA to bring this important medicine to market and add it to our growing global portfolio of more than 700 respiratory products. As one of the leading providers of prescription medicines in the US, we continue to execute on our mission and do our part to reduce costs for patients and identify pathways that help increase sustainability for the US healthcare system overall.”
Mylan President Rajiv Malik added, “We’re pleased to offer the first FDA-approved generic of Advair Diskus, one of the leading treatments for asthma and COPD management today. We’ve long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. This complex product required a rigorous research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway. We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant. This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients.”
Mylan released manufacturing and distribution video for Wixela:
Read the Mylan press release.
