Generic Lovenox approved for anticoagulation

The FDA has granted Sandoz approval of a generic version of Lovenox (enoxaparin sodium injection, from sanofi aventis). Enoxaparin sodium injection is expected to be made available by Sandoz in 30mg/0.3mL, 40mg/0.4mL, 60mg/0.6mL, 80mg/0.8mL, 100mg/mL, 120mg/0.8mL, and 150mg/mL dosage strengths.

Enoxaparin sodium injection is approved for the prevention of deep vein thrombosis (DVT) in hip or knee replacement surgery, or in abdominal surgery or acutely ill patients with severely restricted mobility at risk for thromboembolism. It is indicated in combination with warfarin for inpatient treatment of acute DVT with or without pulmonary embolism (PE), or outpatient treatment of acute DVT without PE. Enoxaparin sodium is also approved in combination with aspirin to prevent ischemic complications of unstable angina and non-Q-wave MI. It is also approved for the treatment of acute ST-segment elevation MI (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI).

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