FDA Approval Sought for New Generic Version of Advair Diskus

Lannett is seeking the approval of a generic form of Advair Diskus (fluticasone-salmeterol powder) in the U.S.

Such an approval would be expected to provide a less-expensive alternative to the inhalation treatment that generated about $3 billion in total U.S. sales for the 12 months ending in February 2021, according to Lannett. 

Originally developed by GlaxoSmithKline (GSK), Advair Diskus is approved as a maintenance therapy to ease breathing difficulties in patients with chronic obstructive pulmonary disease (COPD). It also is approved to treat asthma in children ages four and older, when given twice daily.

The medication contains two active ingredients: fluticasone and salmeterol. Fluticasone is a corticosteroid that can lessen lung inflammation — one of the hallmarks of COPD and asthma — while salmeterol is a long-acting bronchodilator that can relax and widen the airways, making it easier for patients to breathe.

An abbreviated new drug application (ANDA) seeking approval of Lannett’s new generic version of Advair Diskus was submitted to the U.S. Food and Drug Administration (FDA) by its strategic alliance partner, Respirent Pharmaceuticals. The generic, if approved, will be available in three different dose strengths of fluticasone/salmeterol combinations: 100/50 mcg, 250/50 mcg, and 500/50 mcg.

“The ANDA submission of generic Advair Diskus marks a significant advancement toward our goal of adding larger and more durable products to our portfolio,” Tim Crew, CEO of Lannett, said in a press release.

“We anticipate a rigorous FDA review, extending beyond one review cycle, for the ANDA, given this is a complex combination drug/device product, involves two active pharmaceutical ingredients (APIs) and includes multiple dosage strengths,” Crew said.

Respirant and Lannett have an exclusive U.S. distribution agreement, which recently has been extended to 12 years, for this new generic version of Advair Diskus. Under its terms, Lannett will be responsible for distributing the new generic product as soon as it is approved by the FDA, and will be entitled to receive a portion of the net profits once distribution starts.

The FDA approved a different generic version of Advair Diskus, called Wixela Inhub and developed by Mylan, now part of Viatris, in 2019. It was the first generic of the inhaled therapy to be approved in the country.

Crew added that Lannett and Respirent also are working to create a generic version of another inhaled powder treatment developed by GSK, called Flovent Diskus (fluticasone propionate powder inhaler). Flovent Diskus contains an inhaled corticosteroid and is used to treat asthma in children ages 4 and older.

“We continue to build an effective, close working relationship with our colleagues at Respirent — a team that has expertise and a deep working knowledge in developing, filing and manufacturing inhalation products and is committed to bringing affordable respiratory products to market,” Crew said.

Generics are medicines that contain the same active ingredients as the brand-name medications on which they are based. They must undergo regulatory testing and approval, and be proven as safe and effective as the original medication. Generally, generic medications can lower the cost of treatment by introducing more competition into the marketplace.

While the total annual U.S. sales of Advair Diskus are approximately $3 billion, Lannett noted that actual generic market values are expected to be lower.