Definitions for "Orphan drug"
Keywords:  fda, incentive, rare, afflict, fewer
A drug for a rare disease. The indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence
drugs developed for rare diseases and conditions which, in the U.S., affect fewer than 200,000 people or, in the European Union, affect 5 or fewer per 10,000 people. Because sales of orphan drugs are likely to be small compared to their development costs, pharmaceutical companies are awarded exclusive rights to market these medicines for a period of time as an incentive to develop them.
A drug that treats a rare disease.