(RxWiki News) The US Food and Drug Administration (FDA) has approved a generic of a common asthma medication.
This new approval is a generic of Symbicort. This drug is found as an inhaler and contains two medications: budesonide and formoterol fumarate dihydrate.
This drug is approved to treat:
- Asthma in patients 6 years of age and older
- Airflow obstruction and exacerbations for patients with chronic obstructive pulmonary disease (COPD)
This medication is administered two times a day. The combination of medications helps reduce inflammation and relaxes the muscles in the airways to improve breathing.
“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,” said Dr. Sally Choe, director of the FDA's Office of Generic Drugs, in a press release.
Asthma affects the airways in the lungs and causes wheezing, shortness of breath and coughing. According to the National Heart, Lung, and Blood Institute, around 25 million people have asthma. That includes 5 million children.
COPD, which is estimated to affect more than 16 million people, includes emphysema and chronic bronchitis. COPD causes airflow blockage and makes it difficult to breathe.
Common side effects of this new generic of Symbicort may include swelling of nasal passages, oral thrush, upper respiratory tract infection and sinusitis.
This generic approval was granted to Mylan Pharmaceuticals, Inc.
Talk to your health care provider about the best available treatment for your respiratory condition.