Teva gets tentative approval for argatroban

JERUSALEM The Food and Drug Administration has given tentative approval to a generic anticoagulant by Teva Pharmaceutical Industries, Teva announced Thursday.

The FDA gave the authorization to the injected drug argatroban, a generic version of a GlaxoSmithKline drug for treating heparin-induced thrombocytopenia that is branded with the same name. The branded version of the drug has annual sales of around $137 million, according to IMS Health.

A tentative approval means that the generic version of the drug meets the conditions for full approval by the FDA, but it can’t be marketed yet because the patent has not expired.