First Generic Version of COPD Inhaler Advair Diskus Approved by FDA

The first generic version of the inhalation treatment Advair Diskus (fluticasone/salmeterol powder) was recently approved by the U.S. Food and Drug Administration for chronic obstructive pulmonary disease (COPD) and asthma patients.

According to a press release from developer Mylan, the therapy, called Wixela Inhub (fluticasone propionate and salmeterol inhalation powder), is indicated as a twice-daily breathing maintenance treatment for patients ages 4 and older. It will be available in three different dose strengths of fluticasone/salmeterol: 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg.

It is expected to launch in the second half of February following label amendments required by the FDA.

A generic therapy contains the same active components of an existing approved treatment. It functions just like the original patented product, is administered in the same way, and provides the same clinical benefits.

“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in an agency press release.

“Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug,” she added.

Fluticasone is an anti-inflammatory agent that reduces swelling in the airways. Salmeterol is a vasodilator, meaning it relaxes and opens up the airways, facilitating breathing. Several studies have shown that the inhaled combination of the two alleviate COPD symptoms and improve the patient’s breathing ability.

The inhaler treatment has similar benefits in patients with asthma, another chronic lung disease characterized by shortness of breath, wheezing, and difficulty breathing.

Inhalers are considered a combination product because the medication is only compatible with a particular device. The FDA recognizes the challenges faced by companies developing generics for such complex products. Therefore, they have made available several resources that can help the companies streamline their process.

As part of the pre-ANDA program, representatives from the company can meet with FDA officers to seek guidance for the development of these products. FDA also provides publicly accessible guidance documents that explain the regulatory and clinical data requirements, formulation and device recommendations, and forms and application processes for various pharmaceutical products.

In 2013, the FDA published product-specific guidance for those attempting to develop a generic product for Advair Diskus, developed by GlaxoSmithKline.

“We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved,” said Anna Abram, deputy commissioner for policy, planning, legislation and analysis at the FDA.