New Delhi: Drug firm Lupin Monday said it has received tentative nod from the US health regulator to market its antipsychotic Lurasidone Hydrochloride tablets in the US market. The company has received a tentative approval from the United States Food and Drug Administration (USFDA) to market its Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg, Lupin said in a statement.
The product is a generic version of Sunovion Pharmaceuticals Inc’s Latuda tablets in the same strengths, it added.
As per IQVIA MAT June 2018 data, Lurasidone Hydrochloride tablets in the five strengths had annual sales of around USD 3,116 million in the US, Lupin said.
The tablets are indicated for the treatment of adults with schizophrenia, major depressive episodes associated with Bipolar I disorder, it added.
Shares of Lupin Monday closed at Rs 880.45 per share on the BSE, up 4.15 per cent from the previous close.