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Aurobindo Receives FDA Approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg

Published: March 10, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Aurobindo Pharma’s Lurasidone Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), LATUDA® tablets manufactured by Sunovion Pharms Inc.,

Lurasidone Hydrochloride Tablets are indicated for:

  • The treatment of schizophrenia
  • The treatment of depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.