FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

The brand product had annual sales of approximately $137 million in the United States, based on IMS sales data. On Feb. 12, 2010, a bench trial in an ongoing patent litigation was completed in the U.S. District Court for the Southern District of New York.


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Teva Pharmaceutical Industries Ltd.,

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