FDA approves first generic of Symbicort for asthma, COPD

The FDA announced approval of the first generic of Symbicort — budesonide and formoterol fumarate dihydrate — Inhalation Aerosol for the treatment of asthma and COPD, according to an agency press release.

The complex generic drug-device combination product is a metered-dose inhaler. The generic is approved for treatment of asthma in patients aged 6 years and older and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema, according to the release. It should not be used to treat acute asthma exacerbations, according to the FDA.

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

The metered-dose inhaler contains the corticosteroid budesonide and the long-acting bronchodilator formoterol. Two inhalations, twice daily, treat both asthma and COPD by preventing symptoms. The inhaler is approved for 160/4.5 mcg/actuation and 80/4.5 mcg/actuation, according to the release.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting and oral candidiasis for patients with asthma. The most common side effects of this treatment among patients with COPD are nasopharyngitis, oral candidiasis, bronchitis, sinusitis and upper respiratory tract infection, according to the release.

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals.

Complex products are medical products where uncertainty concerning the approval pathway or possible alternative approaches to product development can benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products, according to the release. The FDA noted that since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition. The FDA said addressing the challenges related to complex generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and its efforts to promote patient access and more affordable medications, according to the release.