(RTTNews) – The U.S. Food and Drug Administration has approved generic Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol from Mylan Pharmaceuticals, Inc. It is the first generic Symbicort approved by the FDA for treat asthma and chronic obstructive pulmonary disease or COPD.
The drug is intended for the treatment of two common lung health conditions – asthma in patients six years of age and older, and maintenance treatment of airway obstruction and reduction of exacerbations in patients with COPD , including chronic bronchitis and/or emphysema.
Meanwhile, the combined generic drug complex product, which is a metered-dose inhaler or MDI, should not be used to treat acute asthma attacks.
Budesonide/formoterol, sold under the brand name Symbicort among others, is a fixed-dose combination medication used in the management of asthma or COPD. The drug, which received FDA approval in 2017, was discovered and developed by British major AstraZeneca. According to IQVIA, Symbicort had US brand sales of $3.5 billion for the 12 months ending January 2021.
The combined drug-device product contains both budesonide, a corticosteroid that reduces inflammation, and formoterol, a long-acting bronchodilator that relaxes airway muscles to improve breathing. Two inhalations, twice a day, treat both conditions by preventing symptoms, such as wheezing for asthmatics, and helping to breathe better, for people with COPD.
The FDA has approved the inhaler for two strengths – 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.
Viatris Inc., owner of Mylan Pharma, announced last year that the FDA had granted tentative approval to budesonide/formoterol fumarate dihydrate products as the first generic version of Symbicort.
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