FDA Approves Generic Version of AstraZeneca’s Symbicort to Treat Asthma and COPD

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.

Kindeva Drug Delivery, a contract development and manufacturing organization, and Viatris announced FDA approval of Breyna (budesonide and formoterol fumarate dihydrate inhalation aerosol) on March 16, 2022. A drug-device combination product indicated for patients with asthma or chronic obstructive pulmonary disease (COPD), this product is the first FDA-approved generic version of AstraZeneca’s Symbicort.

The drug-device combination product is a metered-dose inhaler that contains both budesonide, a corticosteroid that reduces inflammation, and formoterol, a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Two inhalations, twice a day, are designed to prevent symptoms in both diseases. Breyna will be available in two strengths: 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.

“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,” said Sally Choe, director of the Office of Generic Drugs in FDA Center for Drug Evaluation and Research, in a press release from the organization. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”

According to a company press release, Breyna is indicated for treatment of asthma in patients six years or older and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. The indication was granted to Mylan Pharmaceuticals, a subsidiary of Viatris.

“The FDA final approval of Breyna, the first FDA-approved generic version of Symbicort, is an exciting milestone both for our company and the many patients living with asthma and COPD,” said Michael Goettler, CEO, Viatris, in the press release. “Our success with this partnership and approval is yet another proof point of the impact of our Global Healthcare Gateway which enables us to join with Kindeva to provide patients in need with new options.”

Sources: Kindeva, FDA