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Generic Version of Symbicort Granted FDA Approval

Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

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By: Charlie Sternberg

Associate Editor

Viatris Inc. and Kindeva Drug Delivery L.P. have announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort  based on an Abbreviated New Drug Application (ANDA). Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).   “The FDA’s tentative approval of generic Symbicort represents yet another significant milestone f...

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