Alembic Pharmaceuticals Limited, a leading pharmaceutical company, announced today that it has received approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lurasidone Hydrochloride tablets (20 mg, 40 mg, 60 mg, 80 mg, and 120 mg).
The approved ANDA has been found to be therapeutically equivalent to Latuda tablets (20 mg, 40 mg, 60 mg, 80 mg, and 120 mg). Latuda tablet is a reference listed drug product (RLD), which belongs to Sunovion Pharmaceuticals Inc.
USFDA-approved Lurasidone Hydrochloride tablets are indicated for monotherapy treatment of adult & pediatric patients between the age of 10 and 17 years with major depressive episode associated with bipolar I disorder (bipolar depression). In addition to this, they are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.
According to IQVIA, one of the world's largest contract research organisations, Lurasidone Hydrochloride tablets (20 mg, 40 mg, 60 mg, 80 mg & 120 mg) have an estimated market size of US$ 3.7 billion for twelve-month ending December 2020.
At the time of market closing on Friday, the share price of Alembic Pharmaceuticals was trading at Rs 938.55, which was a decline of 1.30 per cent over Thursday’s closing price of Rs 950.90 on BSE.