Lupin receives FDA approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg

Deepthi | Myequity news | Date : 07-01-2019 14:45:00 IST

Pharma major Lupin has received approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals, Inc’s 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 & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.

It is indicated for:

•Treatment of adult patients with schizophrenia.

•Monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).

•Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).


Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg had annual sales of approximately USD 3217.3 million in the US (IQVIA MAT September 2018).

About Lupin Limited


Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded &generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.


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