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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.