India, Sept. 11 -- Shilpa Medicare Ltd has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for grant of marketing authorisation for OERIS™, its Ondansetron Extended-Release Injection 100 mg/mL.
The company said OERIS™ is designed as the world's first extended-release ondansetron injectable formulation, offering sustained antiemetic protection for up to 120 hours, or five days, following a single administration. The product will be launched in India and is protected by a patent in the country until 2039.
The approval follows the successful completion of a multicentre, randomised, double-blind Phase III clinical trial evaluating the safety and efficacy...