The U.S. Food and Drug Administration approved the first generic version of Lovenox, an anti-coagulant drug used for multiple indications including prevention of Deep Vein Thrombosis (DVT), a potentially deadly blood clotting condition.

Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally derived complex mixture of sugar molecules.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.

Prior to the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection. After carefully reviewing the petition, the agency determined that current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection. A response to the petition was released by the agency.

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.

According to the National Heart, Lung, and Blood Institute, at least 100,000 cases of pulmonary embolism occur each year in the United States. It is the third most common cause of death among hospitalized patients. This medicine is also used to prevent blood clots in patients confined to bed and also for patients experiencing chest pain and heart attacks.

The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and bruising (hematoma), which may cause long-term or permanent paralysis.

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.