Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.
This is Lupin's first product using proprietary Nanomi B.V.'s (Nanomi) technology and has a 180-day CGT exclusivity.
Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.