FDA Grants Tentative Approval for Symbicort Generic

March 8, 2021 – The U.S. FDA has granted tentative approval for a generic version of AstraZeneca’s Symbicort® (budesonide/formoterol fumarate dihydrate) inhalation aerosol. The generic is manufactured by Viatris Inc. and Kindeva Drug Delivery L.P.

Symbicort and its generic are indicated to treat asthma and chronic obstructive pulmonary disease (COPD) in patients who meet certain clinical criteria. The products combine an inhaled corticosteroid to treat inflammation with an inhaled bronchodilator that helps open the airways. This can help patients with asthma and COPD breathe more easily by preventing airway constriction and can help reduce cumulative damage to the lungs and airways caused by inflammation.

Like other inhaled asthma and COPD treatments, Symbicort is considered a complex drug product. That is because the combination of the medications and the delivery device can be difficult for generic drug manufacturers to replicate.

Approval for Viatris and Kindeva’s generic is tentative based not on clinical data, but on ongoing patent litigation that prevents the entry of competing Symbicort generics in the U.S. marketplace. Full approval for the generic will depend on the expiration of patent protection for Symbicort.