FDA approves first generic Advair Diskus

4 Feb 2019

Mylan's Wixela Inhub is the first FDA-approved therapeutically equivalent generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or COPD.

Mylan has announced the FDA approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus.

FDA approves first generic Advair Diskus
Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP)

Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA last month, which prompted an amendment to the label for certain inhaled corticosteroids, including Advair Diskus and any generic versions. Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.

Mylan CEO Heather Bresch commented: "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 R&D 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 R&D 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."

"Patients enrolled in clinical trials found Wixela Inhub easy-to-use and highly effective at controlling their asthma in a clinical bioequivalence study. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD. We have waited for years for generic inhalers to emerge in respiratory medicine," said Edward Kerwin, MD of Crisor, a division of the Clinical Research Institute located in Medford, Ore. and a Clinical Investigator on the Wixela Inhub clinical program.

Advair Diskus had US sales of $4.2 billion for the 12 months ending 30 November 2018, according to IQVIA.

Read More

Related news

BASF opens Application Technology Laboratory for personal care in Nigeria

BASF opens Application Technology Laboratory for personal care in Nigeria

11 Feb 2019

Local competence in application and formulation technology for sub-Saharan African personal care market.

Read more 
FDA approves first Nanobody-based medicine for adults with aTTP

FDA approves first Nanobody-based medicine for adults with aTTP

10 Feb 2019

Cablivi is the first US approval for Sanofi's new rare blood disorders franchise.

Read more 
Pharmapack Europe 2019 Award Winners

Pharmapack Europe 2019 Award Winners

7 Feb 2019

Awards showcased a wide range of industry-changing discoveries in drug delivery, packaging and automation.

Read more 
Brexit - the EU FMD's painful problem

Brexit - the EU FMD's painful problem

7 Feb 2019

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

Read more 
New series of advanced freeze dryers

New series of advanced freeze dryers

6 Feb 2019

The LyoConstellation series allows the development of highly aggressive cycles and the mapping of the furthest reaches of theoretical design space for a formulation.

Read more 
Hitachi Chemical to acquire apceth Biopharma

Hitachi Chemical to acquire apceth Biopharma

5 Feb 2019

Acquisition will strengthen Hitachi's presence in the second-largest cell and gene therapy market in the world.

Read more 
Sartorius joins the community of the National Institute for Innovation in Manufacturing Biopharmaceuticals

Sartorius joins the community of the National Institute for Innovation in Manufacturing Biopharmaceuticals

3 Feb 2019

Company hopes to contribute substantially to further optimizing and accelerating the current manufacturing processes in the biopharmaceutical industry.

Read more 
Particle Sciences partners with Encube Ethicals to develop novel vaginal rings

Particle Sciences partners with Encube Ethicals to develop novel vaginal rings

31 Jan 2019

The partnership will focus on rings for the administration of existing approved drugs, improving drug effectiveness and patient compliance.

Read more 
Manufacturing consultancy up 150% as life sciences prepare for a digital future

Manufacturing consultancy up 150% as life sciences prepare for a digital future

30 Jan 2019

Increasing appetite for digitised manufacturing and using data to improve GMP manufacturing.

Read more 
SGS expands testing capabilities at its Glasgow facility

SGS expands testing capabilities at its Glasgow facility

29 Jan 2019

Clients will benefit from a fully comprehensive range of validated biosafety methods to support cell bank and viral vaccine manufacturing and lot release of drug product.

Read more