Viatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
Viatris CEO Michael Goettler commented: "The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients.
- Viatris CEO Michael Goettler commented: "The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients.
- The FDA provided tentative approval at this time due to ongoing patent litigation.
- Viatris and Kindeva are committed to bringing a generic Symbicort to market as soon as possible.
- Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems (microsystems), and connected drug delivery.