Generic Deep Vein Thrombosis Drug Cleared by FDA


July 26, 2010

The first generic version of Lovenox (enoxaparin sodium injection), an anticoagulant drug used for multiple indications, including prevention of deep vein thrombosis (DVT), was cleared by the FDA in July 2010.

Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh. Preventing these blood clots can prevent a pulmonary embolism, which is a sudden, potentially fatal, blockage in a lung artery that can occur if the blood clot breaks free and travels through the bloodstream to the lungs. This medicine is also used to prevent blood clots in patients confined to bed and also for patients experiencing chest pain and heart attacks.

Approval of generic enoxaparin sodium injection has been granted to Sandoz Inc. of Broomfield, Colo. The generic product has been approved in the following strengths: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL, and 150 mg/mL. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

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