The first generic drug Proventil HFA (Albuterol Sulfate) metered-dose inhaler, 90 mcg / inhalation, is approved by the Food and Drug Administration (FDA) for the treatment or prevention of bronchospasm in four-year-old patients or older who have reversible obstructive airway disease as well as exercise-induced bronchospasms in this age group.
“The FDA acknowledges the increased demand for albuterol products during the new coronavirus pandemic,” said FDA Commissioner Dr. Stephen M. Hahn. “We are deeply committed to facilitating access to medical products to help address the critical needs of the American public,” added the doctor.
According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles around the airways swell and harden, tightening the airways, making them narrower. Exercise and other physical activities can cause symptoms in most people who have asthma, and this can occur during or immediately after being active. Asthma causes recurrent episodes of wheezing (a wheezing sound when breathing), chest tightness, shortness of breath, and cough. The cough worsens at night or early in the morning. Asthma affects people of all ages, but it often begins during childhood. In the United States, more than 26 million people are known to have asthma, and about 7 million of these 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 the industry through the development process for generic products, including complex combination products, such as metered-dose inhalers, which consist of a medication and a device. The development of many generic combination products may be more difficult than that of oral solid forms, such as tablets.
Under the Generic Drug User Fee Modifications (GDUFA), individual companies may collaborate with the FDA as part of its New Drug Abbreviated Forms (ANDA) program. to assist in the development of such complex generic pharmaceuticals. The FDA also publishes guidance documents that describe the FDA recommended steps that companies must follow to submit complete applications for generic pharmaceuticals.
In March 2020, the FDA released a revised draft of a specific product guide for proposed generic albuterol sulfate metered-dose inhalers including pharmaceuticals that reference Proventil HFA. Among other things, the draft guide provides bioequivalence recommendations.
The FDA requires applicants to submit adequate information and data to demonstrate that the complex generic drug-device meets the agency’s rigorous approval standards. These standards ensure high-quality generic pharmaceuticals that are as safe and effective as equivalent brand name drugs.
The FDA granted approval of this generic albuterol sulfate inhalation spray to Cipla Limited.