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Indian Company’s Drug to Get ‘Orphan’ Drug Status by US FDA

by Dr. Trupti Shirole on March 29, 2011 at 7:25 PM
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 Indian Company’s Drug to Get ‘Orphan’ Drug Status by US FDA

Indian pharmaceutical company Natco Pharma's new anti-cancer drug NRC-AN-019 has been accorded the orphan drug status by the US Food and Drug Administration (FDA). An orphan drug status is designated to a medicine which is useful for treating rare diseases that affect less than 2lakh people in the country. This drug is indicated in brain tumor (glioma), pancreatic cancer and chronic myelogenous leukemia.

Getting an orphan drug status entitles the manufacturers to special incentives which include 7years marketing exclusivity, specific tax credits and waiver of prescription drug user fee, which is about 1.5 million dollars per indication.

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This is the first time that that an Indian company's drug has been given an orphan drug status by the US FDA for 3clinical indications. The clinical trials for this drug are ongoing and the company expects to launch this medicine within 3years. This drug has been patented in 9countries including US.

Source: Medindia
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