The Orphan Drug designation means a drug which is used for treatment of a rare medical condition. The US Food and Drug Administration (USFDA) gives this designation to the drugs which affect less than 200,000 patients in the USA. USFDA extends special incentives to companies involved in the discovery and development of such drugs.
In early 2011, India’s Natco Pharma’s anti‐cancer drug, NRC‐AN‐019, has received ‘Orphan Drug’ designation from the US Food and Drug Administration (USFDA) for three indications ‐ glioma (brain tumour), pancreatic cancer and chronic myelogenous leukemia. This was for the first time that an Indian Company’s drug is designated as orphan drug by the USFDA for three indications.