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News Breaks | | | | January 13, 2013 | | 12:24 EDT |  | TELK | Telik announces orphan drug designation of Telintra
Telik was notified that its product candidate, ezatiostat HCL, Telintra, has been granted orphan drug designation by the US Food and Drug Administration, FDA, for the treatment of myelodysplastic syndrome, MDS. Orphan designation grants potential US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval. Additional potential benefits of orphan designation include development grants, tax credits related to clinical trial expenses, protocol development assistance and exemption from FDA user fees. The US Orphan Drug Act aims to encourage the development of drugs for the diagnosis, prevention and treatment of medical conditions affecting fewer than 200,000 people in the US. | |
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