FDA approves Lupin's generic Latuda

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FDA approves Lupin's generic Latuda

By Sandra Levy - 01/07/2019
The Food and Drug Administration has greenlighted Lupin’s generic Latuda (lurasidone hydrochloride) tablets. They will be available in 20-mg, 40-mg, 60-mg, 80-mg and 120-mg dosage strengths.

The generic Latuda is indicated for the treatment of adult patients with schizophrenia; monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder (bipolar depression); and adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.

Latuda tablets had a market value of approximately $3.2 billion, according to September 2018 data.

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