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FDA Officials OK Lurasidone Hydrochloride Tablets
January 9th 2019
The FDA has approved marketing of Lupin Pharmaceuticals’ Lurasidone Hydrochloride Tablets
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
, 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.
Reference
Lupin receives FDA approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg [news release]. Mumbai, India and Baltimore, MD; January 7, 2019: Lupin Pharmaceuticals website.
. Accessed January 7, 2019.
