Lupin Gets Tentative USFDA Nod Anti Depressant | CORPORATE ETHOS

Lupin Gets Tentative USFDA Nod Anti Depressant

By: | October 15, 2018
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Oct 15: Mumbai-based pharma firm Lupin Ltd on Monday 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 (USFDA).

“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 said.

According to the company, the product 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), and 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 $3116 million in the US (IQVIA MAT June 2018).