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FDA Approves First Generic Injection Drug to Prevent Deep Vein Thrombosis

Posted Jul 24 2010 10:36pm

This is good news in the cost department.  As stated below the name brand drug is made from heparin so I am guessing the same active ingredient is present here.  If a blood clot is detected then there are stents that can be put in place in the legs and you can read more at the link below on how this works.  BD

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.  Approval of generic enoxaparin sodium injection has been granted to Sandoz Blood clot diagram (Thrombus)Inc. of Broomfield, Colorado.

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, Ph.D., deputy director of the FDA’s Office of Pharmaceutical Science.

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 today.

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.

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