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Sandoz have announced the introduction of enoxaparin sodium injection, the first generic version of Lovenox, in the US. Product shipment began immediately following approval by the US Food and Drug Administration (FDA).
According to IMS data enoxaparin sodium injection is the best-selling hospital medicine in the US, and has been described as the ‘goldstandard’ for anti-thrombotic treatments. Lovenox, the reference product, recorded US sales of USD 2.7 billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was launched.
“Sandoz is the first company to launch generic enoxaparin sodium in the US, delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products,” said Jeff George, global head of Sandoz.
“We welcome the FDA decision to approve our enoxaparin application, and are now looking forward to significantly increasing patient and payor access to this vital medicine, by providing a high-quality, more affordable version.”
The Sandoz product, developed in collaboration with Momenta Pharmaceuticals, Inc., is indicated for use in prophylaxis and for treatment of deep vein thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, and the treatment of acute ST-segment elevation myocardial infarction [STEMI]
Enoxaparin, a low molecular weight heparin (LMWH) is an anticoagulant that helps to prevent thrombosis. Thrombosis is the formation of a blood clot in the blood vessels in the absence of bleeding. Enoxaparin is made up of a complex blend of low molecular weight substances (oligosaccharides) derived from heparins, and therefore requires sophisticated analytical methods on the part of the manufacturer to ensure accurate and reliable characterisation, development and production.