Lupin receives tentative FDA approval for generic Lurasidone Hydrochloride Tablets

Deepthi | Myequity news | Date : 15-10-2018 14:55:00 IST


Lupin receives 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 Pharmaceuticals Inc.’s (Sunovion) 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 for bipolar depression, 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 USD 3116 million in the US (IQVIA MAT June 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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