Alembic Pharma gets USFDA approval for bipolar depression drug

Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression.

The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Pharmaceuticals said in a regulatory filing.

Quoting IQVIA data, Alembic Pharma said Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of USD 3.7 billion for the twelve months ending December 2020.

Lurasidone Hydrochloride tablets are indicated for treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

Alembic Pharma said it has settled the case with Sunovion and will launch its generic as per the terms of settlement.

Alembic now has a total of 144 abbreviated new drug application (ANDA) approvals, including 126 final approvals and 18 tentative approvals from the USFDA.

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