FDA clears Amphastar enoxaparin sodium injection

22nd September 2011 (Last Updated September 22nd, 2011 18:30)

The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals' abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection.

The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals' abbreviated new drug application for enoxaparin sodium injection.

The approval has been granted for doses of 100mg/ml and 150mg/ml.

Enoxaparin sodium injection is the generic version of Sanofi's Lovenox. It is indicated for the treatment of deep vein thrombosis and prophylaxis of ischaemic complications in unstable angina and non-Q-wave myocardial infarction.

Amphastar will supply enoxaparin sodium injection to Watson Pharmaceuticals, which will be responsible for the marketing sale and distribution of the product in the US.