Lupin Ltd on Wednesday announced that it has received approval from the US Food and Drug Administration (USFDA) for its generic version of risperidone extended-release injectable suspension, used for the treatment and maintenance of schizophrenia and bipolar disorder in adults.

The approval covers the company’s abbreviated new drug application (ANDA) for risperidone injectable suspension in single-dose vials of 25 mg, 37.5 mg, and 50 mg.

Lupin said this marks its first product developed using Nanomi BV’s proprietary technology and comes with 180-day exclusivity under the Competitive Generic Therapies (CGT) pathway.