First Generic Symbicort Receives FDA Approval - Consumer Health News

TUESDAY, April 12, 2022 (HealthDay News) — The U.S. Food and Drug Administration approved the first generic version of Symbicort (budesonide and formoterol fumarate dihydrate) for inhalation aerosol use for the treatment of asthma in patients 6 years of age and older and for maintenance therapy in chronic patients admitted obstructive pulmonary disease (COPD), the agency announced on March 15.

The FDA states that the generic metered dose inhaler should not be used to treat acute asthma attacks. For the COPD indication, the generic is approved for maintenance therapy of airway obstruction and reduction of exacerbations in patients with chronic bronchitis and/or emphysema.

The drug-device combination product, which contains both budesonide and formoterol fumarate dihydrate, should be administered as two inhalations twice a day, about 12 hours apart, to prevent symptoms such as wheezing in asthma and improve breathing in COPD. Two inhaler strengths were approved: 160/4.5 µg/actuation and 80/4.5 µg/actuation.

In patients with asthma, the most commonly reported side effects of budesonide and formoterol fumarate dihydrate oral inhalation aerosol are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach upset, vomiting and oral side effects candidiasis. In COPD patients, commonly reported adverse reactions include nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.

Mylan Pharmaceuticals Inc. has received approval for Generic Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol.

More information