The U.S. Food and Drug Administration announced Tuesday the approval of the first generic version of Symbicort Inhalation Aerosol for the treatment of asthma and chronic obstructive pulmonary disease (COPD), according to World Pharma News.
Symbicort contains budesonide, a steroid, and formoterol, a long-acting β2-agonist, which is commonly used to treat asthma in patients aged 6 or above. It is also used as maintenance therapy for airflow obstruction, reducing acute exacerbations for patients with COPD, including chronic bronchitis and emphysema.
Generic Symbicort is a metered-dose inhaler and is not advised to treat acute asthma attacks.
Dr. Sally Choe, Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research, said, “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.”
“This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective, and affordable medicines for patients and consumers,” she added.
Last week, the FDA gave tentative approval to generic Symbicort amid the patent dispute between AstraZeneca, the maker of the brand Symbicort, and Viatris, formerly called Mylan Pharmaceuticals.
Earlier this month, the US District Court for the Northern District of West Virginia ruled in favor of AstraZeneca, stating that the challenge over some of the company’s Symbicort patents “are not invalid for obviousness.” Viatris said last week it was planning to appeal the decision.
The FDA approved Symbicort in July 2006. It generated $3.5 billion in sales for AstraZeneca for the 12 months ending in January 2021, according to Viatris.
Asthma is one of the chronic, long-term respiratory conditions affecting the airways in the lungs. The symptoms of asthma include wheezing, shortness of breath, and coughing.
COPD, which includes chronic bronchitis and emphysema, is also a chronic, long-term respiratory condition that causes airflow blockage, making it difficult to breathe.
Some of the most common side effects associated with Symbicort inhalation aerosol are headache, nasopharyngitis (swelling of nasal passages and back of the throat), pharyngolaryngeal (nose and mouth), upper respiratory tract infection, sinusitis, influenza, back pain, and nasal congestion.
The FDA has been taking steps to help guide the generic drug industry by boosting generic drug approvals. It requires companies to submit appropriate data and information to demonstrate that their generic drugs meet the agency’s rigorous approval standards, so it can ensure that generic drugs are as safe and effective as their brand name equivalents.
