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Taro to sell extended phenytoin sodium capsules for epilepsy, neurosurgery
By Elaine Rigoli
Tampa, Fla., Sept. 6 - Taro Pharmaceutical Industries Ltd. has received approval from the Food and Drug Administration for its abbreviated New Drug Application for extended phenytoin sodium capsules, USP 100 mg.
The new Taro product is bioequivalent to Pfizer's Dilantin Kapseals, used for treating seizures related to epilepsy and neurosurgery.
According to industry sources, extended-release phenytoin capsule products have annual U.S. sales of about $191 million.
Taro, based in Hawthorne, N.Y., is a science-based pharmaceutical company.
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