Sanofi-aventis’ sNDA of Lovenox® (Enoxaparin Sodium Injection) for Acute Heart Attack Under USFDA Priority Review
The Supplemental New Drug Application (sNDA) of Sanofi-aventis (NYSE: SNY) for its anticoagualant - Lovenox® (enoxaparin sodium injection) has been accepted by the USFDA and placed at priority review status for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
STEMI is a type of acute heart attack in which an artery is generally completely blocked (due to blood clot formation in the heart arteries) for sufficient time to cause heart muscle damage.
Lovenox® is a low-molecular weight heparin (LMWH) approved in 96 countries with seven indications (which may vary from one country to another) for the prophylaxis and treatment of thromboembolic disease, including prophylaxis of ischemic complications of unstable angina and non-Q-wave (non-ST-segment elevation) myocardial infarction and the prophylaxis of deep-vein thrombosis (DVT), a condition that may lead to pulmonary embolism (PE).
Sanofi-aventis also submitted a filling for Lovenox® in European countries including France, Germany, UK, Italy and Spain.
Read more from the full report.
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