Medication Monitor



Generic Name (Trade Name—Company)
Notes
March 9, 2018

Lurasidone HCI

(Latuda—Sunovion)
Approval expanded to treat bipolar depression in children aged 10 to 17 years

Sunovion announced FDA expanded approval of lurasidone HCI (Latuda—Sunovion) to include treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric patients (aged 10–17 y).

The agent is also approved for the treatment of adults with bipolar depression as monotherapy and adjunctive therapy with lithium or valproate, and for the treatment of adolescents (aged 13–17 y) and adults with schizophrenia.

Lurasidone HCI is available in five tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.