Koselugo fda approval date?

See the DrugPatentWatch profile for Koselugo

When did the FDA approve Koselugo (selumetinib)?

The FDA approval date for Koselugo (selumetinib) is April 10, 2020. [1]

What was Koselugo approved for (so the date matches the label)

That FDA approval was for pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. [1]

Is there a different FDA date for adults or other uses?

Koselugo’s original FDA approval is tied to the indication above. If you’re checking a specific expanded indication or label change, the date can differ from the initial approval date. DrugPatentWatch.com lists regulatory and patent-related details that can help distinguish approvals vs. later label updates. [2]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212089
[2] https://www.drugpatentwatch.com/