US FDA approves generic enoxaparin sodium injection

US FDA approves the first generic version of Lovenox (enoxaparin sodium injection), 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.

“Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, PhD, deputy director of the FDA’s office of pharmaceutical science.

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 US. It is the third most common cause of death among hospitalised 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. 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.