FDA Approves First Generic Of Symbicort To Treat Asthma, COPD

The U.S. Food and Drug Administration approved Mylan Pharmaceuticals, Inc.’s generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol. It is the first FDA- approved generic of Symbicort to treat asthma and chronic obstructive pulmonary disease or COPD.

The drug is for the treatment of two common pulmonary health conditions – asthma in patients six years of age and older, and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD, including chronic bronchitis and/or emphysema.

Meanwhile, the complex generic drug-device combination 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 drug major AstraZeneca. According to IQVIA, Symbicort had U.S. branded sales of $3.5 billion for the 12 months ended January 2021.

The drug-device combination product contains both budesonide, a corticosteroid that reduces inflammation, and formoterol, a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Two inhalations, two times a day, treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those 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, last year had announced that the FDA granted tentative approval of budesonide/formoterol fumarate dihydrate products as the first generic version of Symbicort.

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