India-based pharmaceuticals manufacturer Lupin said it received approval from the US FDA to sell a generic equivalent of Latuda tablets for treating bipolar disorder and schizophrenia in adults.
Latuda, a product of Sunovion Pharmaceuticals, has sales of over $3.2 billion in the US alone, making it one of the bigger drugs in the market.
Permission has been received for selling dosages of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg, Lupin said.
The drug, Lurasidone Hydrochloride, is used to treat adult patients with schizophrenia.
It can also be used by itself (monotherapy) to treat depression in adult patients with bipolar disorder. It can also be used as an adjunctive treatment with lithium or valproate in these patients.
Lupin is one of the world’s biggest makers of generic drugs, and sells both branded & generic formulations, biotechnology products and pharmaceutical ingredients globally.
It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.