FDA Approves First Generic of Symbicort for Asthma and COPD

The FDA has approved the first generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

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

The approval of Breyna was granted to Mylan Pharmaceuticals, a subsidiary of Viatris. The company plans to launch Breyna in 2022 as the upcoming court proceedings develop, according to a statement from Viatris. In December 2021, the U.S. Court of Appeals for the Federal Circuit reversed the infringement judgment against Viatris and ordered the case remanded back to the U.S. District Court for the Northern District of West Virginia for further proceedings. 

Breyna is a metered-dose inhaler (MDI), which 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, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms. The inhaler is approved for two strengths: 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.

The most common side effects for those with asthma are swelling of nasal passages and back of throat, headache, upper respiratory tract infection, nose and mouth pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and thrush. For those with COPD, the most common side effects are swelling of nasal passages and back of throat, thrush, bronchitis, sinusitis, and upper respiratory tract infection.

Asthma impacts about 25 million people, more than five million of whom are children. Asthma is the leading chronic disease in children, according to the Asthma and Allergy Foundation of America. Currently, there are about 5.1 million children under the age of 18 with asthma. COPD afflicts more than 16 million, or 6.6% of adults, reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD), according to the American Lung Association. Rates for both chronic bronchitis and emphysema are greater among non-Hispanic white men and those 65 years of age and older.