FDA Approves Generic Treatment for COPD, Asthma

By Jonathan Springston, Editor, Relias Media

The FDA this week approved a generic version of a common drug used to treat asthma and COPD, a combination of budesonide and formoterol fumarate dihydrate in a metered-dose inhaler.

Sally Choe, PhD, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, called this approval “another step forward in our commitment to bring generic copies of complex drugs to the market” and is part of the agency’s “continued efforts to increase competition and access to quality, safe, effective, and affordable medicines for patients and consumers.”

Patients should use the metered-dose inhaler two times per day to alleviate wheezing (asthma) and to improve breathing (COPD). Budesonide is a corticosteroid that alleviates inflammation, while the bronchodilator formoterol relaxes muscles to help patients breathe easier.

Nearly 25 million and more than 16 million Americans are living with asthma and COPD, respectively. Regarding asthma, the National Heart, Lung, and Blood Institute is sponsoring an adaptive research trial called PrecISE to learn how to better diagnose, manage, and treat severe cases.

For more on this and related subjects, be sure to read the “Pharmacology Update” feature that appears in each issue of Internal Medicine Alert.