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

Vetter's Skokie facility expansion nears completion

Vetter's Skokie facility expansion nears completion

17 Apr 2019

Expansions will help meet an increase in customer projects; a second extension is in the final planning stage.

Read more 
Catalent to acquire gene therapy leader Paragon Bioservices

Catalent to acquire gene therapy leader Paragon Bioservices

16 Apr 2019

Will provide new expertise and capabilities in one of the fastest-growing areas of healthcare.

Read more 
Colorcon expands functional film coatings through the CR Alliance with DuPont

Colorcon expands functional film coatings through the CR Alliance with DuPont

15 Apr 2019

The Aquacoat product line provides modified release drug profiles with the added benefit of global regulatory acceptance.

Read more 
Hovione Technology acquires global rights to new pulmonary inhaler device

Hovione Technology acquires global rights to new pulmonary inhaler device

15 Apr 2019

The Papillon DPI is a single-part, blister-based, reusable inhaler, suitable for both chronic and acute treatments.

Read more 
Exploristics surges ahead with £1m investment

Exploristics surges ahead with £1m investment

15 Apr 2019

The loan will be used to develop KERUS Cloud - currently the only software that can simulate trials with multiple correlated outcomes - by integrating it into an intelligent software ecosystem.

Read more 
Catalent celebrates opening of second Shanghai facility

Catalent celebrates opening of second Shanghai facility

14 Apr 2019

Catalent’s two Shanghai locations will provide sponsors with an optimized supply solution for studies being undertaken in China, the Asia-Pacific region and globally.

Read more 
Global collaboration to innovate more natural and additive-free nutraceuticals

Global collaboration to innovate more natural and additive-free nutraceuticals

12 Apr 2019

Initiative will enable Sirio Pharma to keep abreast of regional trends, new ingredients, dosage forms and claims to provide customers unique product ideas for line extensions.

Read more 
Isotype-specific secondary antibodies for improved signal detection

Isotype-specific secondary antibodies for improved signal detection

10 Apr 2019

Offers an alternative to cross-adsorbed secondary antibodies when absolute specificity is required.

Read more 
Sterling Pharma to acquire CiVentiChem in the US

Sterling Pharma to acquire CiVentiChem in the US

9 Apr 2019

The acquisition will enhance the CDMO's chemistry development capabilities to support pre-clinical and early phase clinical supply.

Read more 
New China-based biotechs fueling growth in manufacturing across China

New China-based biotechs fueling growth in manufacturing across China

9 Apr 2019

New guidelines will see poorer quality manufacturers drop out of the market.

Read more