Lupin gets tentative FDA nod for generic Latuda tablets

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Lupin gets tentative FDA nod for generic Latuda tablets

By Sandra Levy - 10/16/2018
Lupin has received tentative approval from the Food and Drug Administration for lurasidone hydrochloride tablets in 20-, 40 mg, 60 mg, 80 mg and 120 mg dosage strengths.

The product is a generic version of Sunovion Pharmaceuticals’ Latuda tablets, and will be available in 20-, 40-, 60-, 80- and 120-mg dosage strengths.

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.

The product had a market value of approximately $3.1 billion, according to June 2018 IQVIA data.

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