- For Immediate Release:
The U.S. Food and Drug Administration today approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, causing them to squeeze the airways and make them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.
The most common side effects associated with Albuterol Sulfate Metered Dose Inhaler, 90 mcg/Inhalation, are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate (tachycardia), tremor and nervousness.
The FDA regularly takes steps to help guide industry through the development process for generic products, including complex combination products, such as metered dose inhalers, that consist of a drug and a device. The development of many generic combination products can be more challenging than solid oral dosage forms, like tablets.
Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products.
In March 2020, the FDA issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing Proventil HFA. Among other things, the draft guidance provides bioequivalence recommendations.
The FDA requires applicants to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure quality generic drug products are as safe and effective as their brand name counterparts.
The FDA granted approval of this generic albuterol sulfate inhalation aerosol to Cipla Limited.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
