Teva says court finds FDA denial of exclusivity period for IVAX's generic Zocor unlawful

By Angela McDaniels

Seattle, May 1 - Teva Pharmaceutical Industries Ltd. said the U.S. District Court for the District of Columbia has granted Teva's motion for summary judgment on the issue of whether IVAX Corp.'s abbreviated New Drug Application to market a generic version of Merck's Zocor (simvastatin) Tablets, 10, 20 and 40 mg is entitled to a 180-day period of Hatch-Waxman statutory exclusivity.

The court found unlawful the Food and Drug Administration's decision in October 2005 that denied IVAX's citizen's petition on the exclusivity issue and remanded the matter back to the FDA, according to a company news release.

Teva Pharmaceutical is based in Jerusalem, Israel, and develops, manufactures and markets generic pharmaceuticals and active pharmaceutical ingredients. It acquired Miami-based pharmaceutical company IVAX in January.

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