Shilpa Medicare's OERIS gets SEC marketing approval

Shilpa Medicare Limited has received final approval from the Subject Expert Committee (SEC) under CDSCO for marketing authorization of OERIS™ (Ondansetron Extended-Release Injection, 100 mg/mL). This novel complex injectable is the world's first extended-release ondansetron injectable formulation, offering sustained antiemetic action for up to 120 hours (5 days) after a single dose. The approval is based on successful Phase III trials for chemotherapy-induced nausea and vomiting (CINV). The company plans to launch OERIS™ in India, where it has patent protection until 2039. This development is expected to enhance patient convenience and healthcare efficiency, further strengthening Shilpa Medicare's oncology portfolio.