Symbicort Generic Wins FDA Tentative Approval

The FDA has granted tentative approval for the first generic version of AstraZeneca’s Symbicort (budesonide/formoterol) indicated for asthma or chronic obstructive pulmonary disease.

The agency gave only tentative approval to Viatris and Kindeva Drug Delivery because the drug is at the center of ongoing patent litigation involving the generics makers and AstraZeneca.

Once final FDA approval is granted, Kindeva will supply Viatris from its state-of-the-art commercial filling and packaging facility in Northridge, Calif.

Symbicort earned AstraZeneca $2.7 billion in global sales last year.