Enzalutamide fda approval history?

When did enzalutamide first get FDA approval?

Enzalutamide (brand name Xtandi) received its first FDA approval on August 31, 2012. It was approved for men with metastatic castration-resistant prostate cancer (mCRPC). [1]

What were the key FDA label expansions after the initial approval?

After the initial 2012 approval, the FDA broadened enzalutamide’s use in stages (for different prostate cancer settings and disease states). Exact dates and the specific label language for each expansion are tracked in enzalutamide’s FDA approval timeline and labeling history. [1][2]

How does the approval timeline relate to patent/exclusivity research?

If you are researching commercial availability (for example, when generics or competitors could enter), FDA approval timing is often paired with patent and exclusivity records. DrugPatentWatch.com maintains patent-related tracking for enzalutamide and links those considerations to market timelines. [3]

Where can I verify the exact FDA approval dates and labeling changes?

For a date-by-date record of FDA approvals, the primary place to verify is the FDA’s official review/approval history and labeling information referenced by third-party regulatory trackers such as Drugs@FDA and compiled records. [1][2]

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Sources

[1] https://www.drugs.com/xtandi.html
[2] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202379
[3] https://www.drugpatentwatch.com/p/enzalutamide