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SmithKline Albenza literature-based NDA for neurocysticercosis and hydatid disease clears FDA.

Executive Summary

SMITHKLINE ALBENZA FOR NEUROCYSTICERCOSIS AND HYDATID DISEASE APPROVAL by FDA June 11 was based on a literature review of the anthelmintic for the two orphan indications. FDA estimates that about 300 people in the U.S. are diagnosed with neurocysticercosis or hydatid disease each year. Albendazole has been marketed in other countries since 1982 and has been available in the U.S. under compassionate use INDs. Although not approved previously in the U.S., the drug has been cited in the medical literature as standard therapy. The NDA (20-666) for albendazole 200 mg tablets was submitted to the agency Dec. 8.
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