Teva gets tentative approval on generic Argatroban
Teva Pharmaceutical Industries Ltd. said Thursday it received tentative U.S. Food and Drug Administration approval for a generic version of Encysive Pharmaceuticals Inc.'s injectable drug for blood-clotting Argatroban.
Teva, based in Israel, said the drug had annual sales of about $137 million in the U.S. The drug is made by Encysive.
The drug is part of an ongoing patent lawsuit with the owner Encysive, Teva said. Tentative approval is usually given when there is still a patent in effect on a drug or there is an ongoing patent dispute.
Barr Pharmaceuticals is also involved in patent dispute with Encysive over Argatroban.
U.S.-traded shares of Teva fell 51 cents to $63.59 in morning trading.