FDA Authorizes Generic Lurasidone Hydrochloride Tablets – APhA submits compounding comments to FDA. – (866) 348-2889.
The FDA has approved marketing of Lupin Pharmaceuticals’ Lurasidone Hydrochloride Tablets, a generic version of Sunovion Pharmaceuticals, Inc’s lurasidone HCl (Latuda) tablets, according to the company. Both products are approved for 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
According to Lupin’s announcement, its Lurasidone Hydrochloride Tablets are indicated for treatment of adult patients with schizophrenia, monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder, and adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.