FDA APPROVES TARO'S GENERIC EXTENDED-RELEASE PHENYTOIN

Taro Pharmaceutical Industries has received approval from the FDA for its abbreviated new drug application for extended-release phenytoin capsules 100 mg.

Phenytoin is prescribed for treating seizures related to epilepsy and neurosurgery. The Taro product is bioequivalent to Pfizer's Dilantin Kapseals. According to industry sources, extended-release phenytoin capsule products have annual U.S. sales of approximately $191 million.

In addition, Taro Pharmaceuticals Ireland received approvals from the FDA in August for sodium chloride injection 0.9 percent and water for injection, packaged in single-dose plastic ampules. These are the first two ANDA approvals received by Taro's Irish affiliate.