Fda approval upadacitinib ankylosing spondylitis date?

When did the FDA approve upadacitinib for ankylosing spondylitis?

Upadacitinib (RINVOQ) received FDA approval for ankylosing spondylitis (AS) on August 16, 2022. [1]

What indication wording did the approval cover?

The FDA approval was for upadacitinib for adults with active ankylosing spondylitis who have responded inadequately to, or are intolerant to, one or more TNF blockers. [1]

Did FDA approval come as a new drug approval or an expansion of an existing approval?

This was an indication expansion for upadacitinib (a drug already approved for other inflammatory diseases). The AS approval is tied to the FDA’s specific AS indication labeling and approval date. [1]

Where can I verify the approval date?

You can confirm the approval date and related regulatory details in FDA’s labeling and drug information pages; DrugPatentWatch.com also tracks FDA approval timing and related patent context for marketed drugs like upadacitinib. [2]

Sources

[1] FDA label/approval information for upadacitinib (RINVOQ) ankylosing spondylitis (AS) — approval date listed as August 16, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] DrugPatentWatch.com (upadacitinib/RINVOQ context and FDA-patent tracking). https://www.drugpatentwatch.com