Viatris wins FDA approval for first generic of AstraZeneca’s Symbicort
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Viatris (NASDAQ:VTRS) shares are trading marginally higher in the post-market Tuesday after the U.S. Food and Drug Administration (FDA) greenlighted the first generic for Symbicort, a respiratory disease therapy marketed by AstraZeneca (NASDAQ:AZN).
The FDA granted the approval for Mylan Pharmaceuticals, which joined Pfizer (NYSE:PFE) spinoff Upjohn to form Viatris (VTRS) in 2020.

The FDA has cleared the inhalation aerosol of the drug known as budesonide and formoterol fumarate dihydrate for two common health conditions related to lungs: asthma and chronic obstructive pulmonary disease (COPD).
âTodayâs approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,â remarked Sally Choe, the director of the FDA's Office of Generic Drugs.
Symbicort generated $2.7 billion revenue for AstraZeneca (AZN) in 2021 with a ~2% YoY decline in constant currency terms.