FDA APPROVED Generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol with woman using 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 said Tuesday.

In asthma, the combination is indicated for adults and children over 6 years of age to prevent symptoms (not in acute attacks); In COPD, the inhaler is approved as maintenance therapy 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 widely prescribed complex drug combination products used to treat asthma and COPD is another step in our quest to bring to market generic copies of complex drugs that can improve and help improve the quality of life, reducing the cost of treatment,” said Sally Choe, PhD, who heads the FDA’s Office of Generic Drugs, in a statement. “This reflects the FDA’s continued efforts to increase competition and access to high-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 — create regulatory uncertainty for generic drugmakers. “Because drug-device combination products can be more difficult to develop, there are fewer, leading to less competition in the marketplace,” the FDA noted.

On Tuesday, Mylan Pharmaceuticals was granted generic approval for the budesonide-formoterol inhaler.

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

Common side effects of the product in asthma patients include back pain, headache, flu, 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.

  • Ian Ingram is Managing Editor at MedPage Today and helps with oncology reporting for the site.

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