FDA Approves First Generic, Metered-Dose Inhaler for Asthma, COPD

The US Food and Drug Administration (FDA) has approved the first generic of Symbicort Inhalation Aerosol (budesonide and formoterol fumarate dihydrate), a metered-dose inhaler, for the treatment of asthma and chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.  

This complex drug-device combination product is approved for use in individuals aged 6 years or older. The product is to be used twice daily 12 hours apart for 2 inhalations to prevent symptoms and help with better breathing and airflow obstruction. Two doses are currently approved: 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.

Common adverse events for individuals with asthma include nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryneal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. This medication should not be used to treat acute asthma attacks.

Nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infections are among the common adverse events associated with use in individuals with COPD.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” concluded the FDA’s director of the Office for Generic Drugs Sally Choe, PhD.

“This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective, and affordable medicine for patients and consumers.”

—Leigh Precopio

Reference:

FDA approves first generic of Symbicort to treat asthma and COPD. News release. US Food and Drug Administration; March 15, 2022. Accessed March 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd