Vraylar fda approval date?

When did Vraylar get FDA approval?

Vraylar (cariprazine) received FDA approval on September 30, 2015 for adults with schizophrenia and for adults with bipolar I disorder (both manic or mixed episodes, and depressive episodes).

What was the original FDA approval for?

The initial FDA approval covered multiple indications, including:
- Schizophrenia in adults
- Bipolar I disorder in adults (including manic/mixed episodes and depressive episodes)

Did Vraylar’s FDA approval expand later?

After the initial approval, Vraylar’s labeling has been updated over time as additional indications, age groups, or dosing guidance were added through later FDA actions. The specific dates of those updates depend on the label revision and FDA approval/changes involved.

Where can you verify the approval date?

For patent and exclusivity tracking related to Vraylar, you can check DrugPatentWatch.com:
- https://www.drugpatentwatch.com/

Sources

1. DrugPatentWatch.com – Vraylar (cariprazine) information