Lupin Receives Tentative FDA Approval for Generic Lurasidone Hydrochloride Tablets

Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg is the generic version of Sunovion’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. It is indicated for the treatment of:

• Adults with schizophrenia.
• Monotherapy treatment of adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression).
• Adjunctive treatment with lithium or valproate in adult patients with major depressive episodes associated with bipolar I disorder.

Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg had annual sales of approximately USD 3116 million in the US (IQVIA MAT June 2018). – Medical Buyer Bureau