If the company meets certain specifications of the FDA and if the drug receives marketing approval, the Orphan Drug designation entitles the company to seven years of marketing exclusivity, exemption from registration fees in the application of new drugs, and tax credits for clinical research. The designation does not shorten the duration of the regulatory process for review and approval.
Yondelis enrolled 650 patients in 110 hospitals across 16 countries for its phase iii trials in ovarian.
orphan drug status
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