Natco Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for anti-cancer drug NRC-AN-019 for glioma, pancreatic cancer and chronic myelogenous leukaemia.
The Indian company is close to completing the Phase I clinical trial of NRC-AN-019 in India, and is planning to conduct further clinical trials in the US and other countries.
Orphan drug designation is granted to drugs that treat rare diseases affecting less than 200,000 patients in the US.
FDA grants special incentives to the companies involved in the development of these drugs, such as seven-year marketing exclusivity, specific tax credits and a waiver of prescription drug user fees.
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