New Hope for Bipolar & Schizophrenia Patients : Lupin gets FDA Approval on Risperidone LAI

PharmaGenDRx News Bureau- 6th September,2025

2:00 PM IST

Lupin, India’s one of the leading multinational pharmaceutical companies receives approval from US FDA for its abbreviated New Drug Application for Risperidone for ER injectable suspension targeted to be used as an adjunct therapy in schizophrenia and management of bipolar disease.

This was a milestone achievement for the company as its first product using Nanomi, a long acting injectable (LAI) preparation platform. It has been exclusively granted a 180 Day subsidiary with 180-day marketing period in the USA under Competitive Generic Therapy (CGT) exclusivity that prioritizes the development of innovative dosage forms to improve health care of patients by imparting potential therapeutic effect for a longer time.

The launch of this drug strengthens Lupin’s position in the market of complex generics and brings new hope for patients.

By Sweta Nandi