FDA approves Amphastar Enoxaparin Sodium Injection

The US Food and Drug Administration has approved Amphastar Pharmaceuticals’ abbreviated new drug application for Enoxaparin Sodium Injection.The approval has been granted for 100mg/ml and 150mg/ml strengths.

Enoxaparin Sodium Injection is the generic version of Lovenox of Sanofi-aventis and is indicated for the treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.

Under an agreement signed with Watson Pharmaceuticals, Amphastar is responsible to supply the drug to Watson, which will be responsible to market, sell and distribute Enoxaparin Sodium Injection in the US.