FDA Approves Mylan Symbicort Generic

FDA has approved Mylan’s generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for treating asthma in patients age 6 and older and maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. An agency announcement says the drug-device combination product is a metered-dose inhaler containing a corticosteroid and a long-acting bronchodilator.

The most common side effects associated with the drugs for those with asthma are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis, FDA says. The most common COPD side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.