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Latuda FDA Approval History

FDA Approved: Yes (First approved October 28, 2010)
Brand name: Latuda
Generic name: lurasidone
Dosage form: Tablets
Company: Dainippon Sumitomo Pharma America, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

Development timeline for Latuda

DateArticle
May  1, 2024NRx Pharmaceuticals Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression
Mar  6, 2018Approval FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
Jan 28, 2017Approval Sunovion’s Latuda (lurasidone) Receives FDA Approval to Treat Adolescents with Schizophrenia
Jul  1, 2013Approval Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
Oct 28, 2010Approval FDA approves Latuda to treat schizophrenia in adults
Mar 10, 2010Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia
Jan  6, 2010Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia

See also

Latuda (lurasidone) Consumer information

Further information

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