Supplier News Breaks Archives
Watson: Court stays injunction for Lovenox generic
January 26th, 2012
PARSIPPANY, N.J. – A federal appeals court has granted Watson Pharmaceuticals Inc. and Amphastar Pharmaceuticals a stay of the preliminary injunction preventing them from marketing or selling Amphastar's enoxaparin sodium injection.
Watson said Thursday that the stay was granted by the United States Court of Appeals for the Federal Circuit and that the company and Amphastar immediately plan to launch their blood thinner product, a generic equivalent of sanofi-aventis' Lovenox.
An anticoagulant, enoxaparin is indicated for the treatment or prevention of deep vein thrombosis, which can lead to blood clots in the lungs, as well as to prevent blood vessel complications in angina and heart attacks.
According to Watson, the Food and Drug Administration in September approved Amphastar's Abbreviated New Drug Application (ANDA) for its enoxaparin sodium injection in strengths of 30mg/ml, 40mg/ml, 60mg/ml, 80mg/ml,100mg/ml, 120mg/ml, 150mg/ml and 300mg/ml. Watson said it has the exclusive right to distribute the product in the U.S. retail pharmacy channel.
The company added that the Federal Circuit court's order doesn't represent a final decision regarding the pending appeal or the underlying litigation.