FDA Approves First Generic Advair Diskus

Anjoli Punjabi, Pharm.D., MPH, Federally Qualified Urban Health Network

The U.S. Food and Drug Administration (FDA) has approved the first generic Advair Diskus inhaler. “[The] 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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. The generic inhaler has been approved in patients 4 years of age and older and is available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.

The approval of generic inhalers can often be more difficult than the approval of other generic agents, such as a solid oral dosage form. This is because inhalers are considered “combination products” given they contain both a drug and device. The FDA recognizes the challenges that exist for companies to gain approval for combination products and has a support mechanism in place to address this.  For example, individual companies can meet with the FDA as part of their Pre- Abbreviated New Drug Application (Pre-ANDA) program to support the development of combination products. In 2013, the FDA published guidance documents to support the Pre-ANDA approval process including formulation and device considerations.

Patients living with asthma and COPD have a critical need for inhalers to manage their disease state. The introduction of the generic Advair Diskus inhaler is step towards increased market competition and increased access to inhaler therapy. 

Reference:

  1. FDA approves first generic Advair Diskus [News Release]. U.S. Food and Drug Administration. 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-g...