Lupin gets USFDA nod for schizophrenia drug

The drug maker said that it received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

The approved ANDA is generic equivalent to Rexulti tablets of Otsuka Pharmaceutical Company. The drug is used to treat certain mental/mood disorders such as schizophrenia, depression. This product will be manufactured at company's Pithampur facility in India.

Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of $1,575 million in the U.S. (IQVIA MAT December 2022).

Meanwhile, the company announced that its alliance partner, Caplin Steriles received final approval from the USFDA to market Rocuronium Bromide Injection and Thiamine Hydrochloride Injection USP.

Mumbai-based Lupin is a transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company reported 71.9% drop in net profit to Rs 153.5 crore despite of 3.8% rise in net sales to Rs to Rs 4,244.6 crore in Q3 FY23 over Q3 FY22.

The scrip rose 0.26% to Rs 647.90 on the BSE.

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