Teva gets US FDA's tentative nod to market generic Argatrobar injection
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.