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Ubrogepant fda approval date?

See the DrugPatentWatch profile for Ubrogepant

When was ubrogepant first approved by the FDA?

Ubrogepant (Ubrelvy) received FDA approval on December 23, 2019. [1]

What product and indication was that approval for?

That initial FDA approval was for ubrogepant for acute treatment of migraine in adults (the condition for which Ubrelvy was first marketed). [1]

Does the approval date differ by formulation or subsequent label changes?

The core “FDA approval date” commonly refers to the original marketing approval date. Any later changes (such as expanded dosing regimens or label updates) do not change the original approval date of the drug product. [1]

Source

  1. DrugPatentWatch.com – Ubrelvy (ubrogepant) FDA Approval Date


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