FDA Approves First Generic Lovenox Injection to Prevent DVT

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The US Food and Drug Administration approved the first generic version of Lovenox (enoxaparin sodium injection) on Friday, July 23. Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug used in the prevention of deep vein thrombosis (DVT), a potentially deadly blood clotting condition.

The generic Lovenox will be manufactured by Novartis AG’s Sandoz unit in Broomfield CO and marketed by Momenta Pharmaceuticals of Cambridge, MA.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate that it contains the same active ingredient as the brand-name medication. Deputy Director of the FDA’s Office of Pharmaceutical Science, Keith Webber PhD, said “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.”

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Lovenox is a widely used drug (15th best-selling in the world) that can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh. If a blood clot breaks free and travels to the lungs, it can cause a fatal blockage called a pulmonary embolism. According to the National Heart, Lung and Blood Institute (NHLBI), at least 100,000 cases of pulmonary embolism occur each year in the United States.

Read: DVT Risk and Prevention Everyone Should Know

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.

The generic enoxaparin sodium injection, which will be called M-Enoxaparin, 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.

Sandoz noted that the product will begin shipping immediately.

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