FDA Approves First Generic Lovenox Injection to Prevent DVT
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.”
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.
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.