Court Places No Restrictions On Generic Lovenox
From Associated Press (July 27, 2010)
CAMBRIDGE, Mass. -- Biotechnology company Momenta Pharmaceuticals Inc. said Tuesday a federal court placed no restrictions on the sale of a generic version of Sanofi-Aventis SA’s Lovenox, an injected drug that prevents blood clots.
Momenta, which is based in Cambridge, Mass., said Sanofi has filed a lawsuit that asked, among other things, for a temporary restraining order and preliminary injunction directing the Food and Drug Administration to suspend its approval of the generic, known by its chemical name enoxaparin.
The U.S. District Court for the District of Columbia held a status conference Monday and scheduled a hearing for Aug. 17.
Last week, Momenta said the FDA had approved the generic, which it developed under a collaboration agreement with Sandoz, the generics business of Swiss drug maker Novartis AG.
Enoxaparin can prevent blood clots in deep veins, as in the thigh or lower leg, which can break free and cause a fatal blockage in a lung artery. At least 100,000 such clots occur in the U.S. each year. They are the third-most common cause of death in hospitalized patients.
The drug can also be used to prevent blood clots in patients suffering a heart attack or chest pain, or those confined to bed.
Israel’s Teva Pharmaceutical Industries Ltd. also is developing a generic version of Lovenox.
Posted: July 2010