Impax Labs pursuing FDA approval for generic cholesterol-lowering drug

HAYWARD, Calif. Generic drug maker Impax Labs is hoping to win approval for a generic cholesterol-lowering drug.

Impax said it had filed an application with the Food and Drug Administration for approval of a version of Merck & Co.’s Vytorin (ezetimibe and simvastatin) in the 10 mg/80 mg strength. Vytorin had sales of around $222 million during the 12-month period ended June 30, according to Wolters Kluwer Health.

Impax’s application contained a paragraph IV certification, a legal assertion that the patents covering Vytorin are invalid, unenforceable or won’t be infringed. In response, under the provisions of the Hatch-Waxman Act of 1984, Merck subsidiaries Schering Corp. and MSP Singapore Co. filed suit for patent infringement against Impax in the U.S. District Court for the District of New Jersey. The suit puts a stay on the FDA’s approval of the drug until Impax goes to trial and wins or until the companies resolve the matter before the court.

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