FDA approves first ProAir HFA generic
The FDA has approved the first generic of ProAir HFA inhalation aerosol — albuterol sulfate — for the treatment or prevention of bronchospasm with reversible obstructive airway disease, such as asthma, and the prevention of exercise-induced bronchospasm in patients aged 4 years and older, according to a press release.
“[The] approval of the first generic drug product for one of the most commonly used rescue inhalers in the U.S. is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market,” FDA Commissioner Stephen M. Hahn, MD, said in the agency press release.
Approval of this specific generic albuterol sulfate inhalation aerosol was granted to Perrigo Pharmaceutical Co., according to the release.
The release also stated that under the Generic Drug User Fee Amendments, individual companies can meet with the FDA as part of its pre-abbreviated new drug application program to support the development of complex drug products, such as metered-dose inhalers that consist of a drug and a device. The FDA also publishes guidance documents describing the steps the agency recommends companies take to submit complete applications for generic drug products.
In 2016, the FDA issued draft product-specific guidance for proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing ProAir HFA (Teva Respiratory), which provided bioequivalence recommendations, according to the release.
“Metered-dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery. As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval. Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” Hahn said.