Sandoz said that its Enoxaparin has been developed under an agreement signed between Momenta Pharma and Sandoz.
Enoxaparin is therapeutically equivalent to the reference-listed drug, Lovenox, which is marketed by Sanofi-Aventis.
Sandoz claimed that Enoxaparin is a low molecular weight heparin (LMWH) and is an anticoagulant that helps to prevent thrombosis.
Enoxaparin 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].
Sandoz and Momenta said that collaborating since 2003, both the companies have provided the FDA with substantial data that demonstrated the equivalence of the Sandoz generic to Lovenox, and addressed potential immunogenicity issues.
Jeff George, global head of Sandoz, said: “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.
“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.”