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Teva gets US FDA's tentative nod to market generic Argatrobar injection
Jerusalem | Saturday, March 27, 2010, 08:00 Hrs  [IST]

Teva Pharmaceutical Industries Ltd announced that the US 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 US$ 137 million in the United States, based on IMS sales data. On February 12, 2010, a bench trial in an ongoing patent litigation was completed in the US District Court for the Southern District of New York.

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