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Abbreviated NDA Filed for Generic Version of Enoxaparin
BRIDGEWATER, N.J., April 7 /PRNewswire-FirstCall/ -- Aventis learned today of new information on the U.S. Food and Drug Administration's (FDA) Web site indicating that an Abbreviated New Drug Application (ANDA) for a generic version of Clexane® /Lovenox® (enoxaparin sodium injection) has been received by the Office of Generic Drugs.
However, Aventis has not yet received official notice from the ANDA filer, and cannot confirm the filing at this time. Aventis intends to provide further comment after it has received official notice from the ANDA filer.
Clexane® /Lovenox® is the only low-molecular-weight heparin (LMWH) in the United States approved by the FDA for seven different clinical indications. Clexane® /Lovenox® is the most widely used and studied LMWH, with numerous national and international clinical studies demonstrating its safety and efficacy. Numerous clinical studies have demonstrated the product's benefits as a safe and effective way to significantly reduce the incidence of deep vein thrombosis in a wide range of patient populations, and as effective prophylaxis of ischemic complication of unstable angina (UA) and non-Q wave myocardial infarction (NQWMI) when administered concomitantly with aspirin. The safety and efficacy of Clexane® /Lovenox® is reflected by more than 15 years of use in the treatment of 100 million patients in 96 countries.