Shilpa Medicare secures CDSCO approval for launch of OERIS? in India

Shilpa Medicare announced that the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has issued final approval for grant of marketing authorization for OERIS? (Ondansetron Extended-Release Injection, 100 mg/mL).

OERIS? is designed to be the world's first extended-release ondansetron injectable formulation, providing sustained antiemetic action for up to 120 hours (5 days) following a single administration - a first-of-its-kind approval in both India and globally.

OERIS? will be launched in India and enjoys patent protection in India until 2039. OERIS? is designed to be the world's first extended-release ondansetron injectable formulation providing sustained antiemetic protection for up to 120 hours (5 days) following a single administration.