Express Pharma

Lupin receives tentative FDA approval for generic Lurasidone Hydrochloride tabs

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The drug is indicated for the treatment of adults with schizophrenia

Lupin 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 Pharmaceutical’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) 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.

 

 

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