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Eisai receives orphan drug designation for thyroid cancer drug

2/14/2013

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.


The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.


The FDA grants the designation under the Orphan Drug Act for products that treat, diagnose or prevent a rare disease or disorder affecting fewer than 200,000 people in the United States. Orphan drug designation entitles a company to tax credits, extended market exclusivity following regulatory approval and other benefits.




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