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.
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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.
