The U.S. FDA (Food and Drug Administration) announced it has approved the 1st generic version of enoxaparin sodium injection (Lovenox), an anti-coagulant (blood thinner) used for the prevention of DVT (deep vein thrombosis), as well as some other therapies.
Lovenox is made from heparin and was approved for use in the USA in 1993. It is a blood-thinning medication whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For the FDA to approve a generic drug, the manufacturer needs to show that it contains the same active ingredient as the brand-name product. In the case of a natural product, such as enoxaparin, the process may be more complex.
Keith Webber, Ph.D., deputy director of the FDA’s Office of Pharmaceutical Science 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.
The FDA had received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection prior to approval. After a careful review of the petition, the agency decided that the currently available scientific evidence, precedent, and the 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 FDA yesterday (23rd July).
Enoxaparin therapy can prevent deep vein thrombosis – the formation of a clot in a deep vein, especially the lower thigh, which can result in a sudden pulmonary embolism.
A pulmonary embolism (pulmonary meaning “of the lungs” from the Latin pulmonarius) occurs when an embolus blocks blood flowing through an artery that feeds the lungs. Typically, a blood clot first forms in an arm or leg (deep venous thrombosis or DVT) and then eventually manages to break free. The embolus can travel throughout the circulatory system towards the lungs, but eventually it is too large to pass through the small vessels of the lungs and forms a blockage. This prohibits blood from flowing into an area of the lung, and the part of the lung dies because it does not receive oxygen.
There are over 100,000 cases of pulmonary embolism in the USA annually. Among hospitalized patients it is the third most common cause of American deaths. This medication is also used to prevent blood clots in patients with chest pains, heart attacks, as well as individuals who are confined to bed.
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.
Source: FDA
Written by Christian Nordqvist