Aurobindo Receives FDA Approval for Cariprazine Capsules, 1.5 mg, 3 mg, and 6 mg
Published: December 16, 2025
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Cariprazine Capsules, 1.5 mg, 3 mg, and 6 mg. Aurobindo Pharma’s Cariprazine Capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Vraylar Capsules manufactured by AbbVie Inc.
Cariprazine Capsules are indicated for:
- Treatment of schizophrenia in adults
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
