PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. announced that Amphastar Pharmaceuticals Inc. has received Food and Drug Administration approval for enoxaparin sodium injection, a blood thinner, in strengths of 100mg/ml and 150mg/ml.
Watson said Monday that according to the companies’ exclusive distribution agreement, Amphastar will supply enoxaparin sodium injection to Watson, which will market, sell and distribute the product to the U.S. retail pharmacy channel.
Amphastar is preparing for the product launch and expected to ship the medication in the fourth quarter, according to Watson..
Enoxaparin sodium injection is the generic equivalent to Sanofi-aventis’ Lovenox and is a low molecular weight heparin indicated in the prophylaxis and treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, the companies said.
For the 12 months ended July 30, Lovenox and its generic equivalents had total U.S. sales of about $2.6 billion, according to IMS Health data provided by Watson.