FDA clears generic asthma inhaler, inhaled corticosteroid
Inhaler is the first generic approval of its kind.
FDA cleared the first generic asthma inhaler of its type, along with generic inhaled corticosteroid powder.
The first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol (Perrigo Pharmaceutical) was approved for patients four years and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm.
Related: Express Scripts Reveals Digital Health Formulary Coverage
“Today’s 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,” says FDA Commissioner Stephen M. Hahn, MD, in a press release.
Metered dose inhalers are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery, Hahn says.
“As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval…Getting more generic copies of complex drugs to the market is a key priority for how we’ll help bring new savings to consumers,” he adds.
Related: Asthma Drug Can Now Be Self-Administered Via Pen
Separately, FDA approved generic ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder (Teva Respiratory LLC) an inhaled corticosteroid (ICS) delivered via Teva’s Digihaler™ device.
The ArmonAir® Digihaler contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma.
It is indicated for the maintenance treatment of asthma in patients 12 years and older.
Read more: Express Scripts Report: Top Drug Classes Driving Spending Growth
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
