Key Development
Shilpa Medicare Limited has received final approval from the Subject Expert Committee (SEC) under CDSCO for grant of marketing authorization for OERIS™ (Ondansetron Extended-Release Injection, 100 mg/mL).
Product Details
OERIS™ is described as the world's first extended-release ondansetron injectable formulation designed to provide sustained antiemetic action for up to 120 hours (5 days) following a single administration. This represents a first-of-its-kind approval both in India and globally. The product enjoys patent protection in India until 2039.
Clinical Basis for Approval
The SEC's approval is based on the successful completion of a multicenter, randomized, double-blind Phase III trial that evaluated the safety and efficacy of OERIS™ for the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately-to-highly emetogenic chemotherapy.
Benefits and Differentiation
The innovative formulation reduces repeat injections to a single dose administered once every five days, significantly enhancing patient convenience and optimizing healthcare staff efficiency.
Commercialization Plans
Upon receipt of final marketing authorization from CDSCO, Shilpa plans to initiate commercial launch across India. The product will be launched in the Indian market.
Management Commentary
Mr. Vishnukant Bhutada, Managing Director, stated that this approval "marks a pivotal moment in our journey to redefine supportive cancer care" and "underscores our dedication to developing complex, patient-first formulations that address real clinical gaps." He further noted that this milestone "solidifies our differentiated oncology portfolio and propels us closer to our vision of becoming a globally recognized leader in specialty pharmaceuticals and advanced drug delivery systems."
Financial Impact
Financial impact not quantified in the disclosure.