First Generic OK'd for Popular Asthma, COPD Inhaler

The first generic version of Symbicort -- a metered-dose inhaler that combines the corticosteroid budesonide with the long-acting bronchodilator formoterol -- has been approved for asthma and chronic obstructive pulmonary disease (COPD), the FDA announced on Tuesday.

In asthma, the combination is indicated for adults and kids ages 6 and older to prevent symptoms (not for acute attacks); in COPD, the inhaler is approved as a maintenance treatment to improve breathing and reduce exacerbations, including for patients with chronic bronchitis or emphysema.

"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, who heads the Office of Generic Drugs at FDA, said in a statement. "This reflects the FDA's continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers."

In the agency's announcement, they noted that "complex products" -- such as a drug-device combination -- result in regulatory uncertainty for generic drugmakers. "Since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition," FDA noted.

Tuesday's generic approval of the budesonide-formoterol inhaler was granted to Mylan Pharmaceuticals.

For both asthma and COPD, the inhaler is used twice daily roughly 12 hours apart, typically in the morning and night. The budesonide-formoterol formulation comes in two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), with the corticosteroid reducing inflammation and the long-acting bronchodilator relaxing airway muscles to improve breathing.

Common side effects with the product in asthma patients include back pain, headache, influenza, nasal congestion, nasopharyngitis, oral candidiasis, pharyngolaryngeal pain, stomach discomfort, sinusitis, upper respiratory tract infections (URIs), and vomiting. In COPD, common side effects include bronchitis, nasopharyngitis, oral candidiasis, sinusitis, and URIs.

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