The U.S. Food and Drug Administration (FDA) has announced its approval for the first generic version of Symbicort Inhalation Aerosol. The generic version, budesonide and formoterol fumarate dihydrate, will be prescribed to treat asthma and chronic obstructive pulmonary disease (COPD).

According to the FDA, asthma is a chronic respiratory condition that affects more than 25 million people. More than 20% of people with the disease are children. Asthma often begins during childhood with symptoms of coughing, shortness of breath, and wheezing. These symptoms are often triggered or intensified by physical activity and can affect the individual through adulthood.

COPD afflicts more than 16 million people, according to the National Heart, Lung, and Blood Institute. COPD is not a specific disease, but includes infections and conditions like emphysema and chronic bronchitis. COPD affects the individual over a long-term period, causing airway blockage and difficulty breathing.

With the approval of the generic version of Symbicort, both of these conditions can be addressed. This generic drug-device combination is a metered-dose inhaler (MDI). Unlike emergency inhalers, an MDI cannot be used immediately, but instead is used periodically to prevent symptoms of asthma or COPD.

The inhalation device contains budesonide, a corticosteroid, to reduce inflammation of the respiratory system, and a bronchodilator called formoterol to relax the muscles in the airways and keep them open. By taking two inhalations twice a day approximately 12 hours apart, the device has been shown to prevent wheezing for those with asthma, and improve breathing for those with COPD.

The FDA has stated that the most common side effects associated with the generic depend on the condition being treated. Patients with asthma reported experiencing:

  • Back pain
  • Headache
  • Influenza
  • Nasal congestion
  • Nausea
  • Pharyngolaryngeal (nose and mouth) pain
  • Swelling of nasal passages and back of throat (nasopharyngitis)
  • Sinusitis
  • Thrush (oral candidiasis)
  • Upper respiratory tract infection
  • Vomiting

Patients with COPD reported experiencing bronchitis, nasopharyngitis, sinusitis, thrush, and upper respiratory tract infection.

Dr. Sally Choe, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, stated in the announcement that the “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.” 

Dr. Choe went on to note that the FDA believes that the increase in generic versions of name-brand drugs will increase competition to create wider access to affordable and effective medicine.