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UPDATED: FDA Approves First Generic Enoxaparin Sodium Injection

Saturday, July 24, 2010 Drug News J E 4
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NOTE TO EDITORS: In response to multiple questions about the product's indications, the press release was revised to clarify that Sandoz's enoxaparin soldium for injection was approved for all of the same indications as Lovenox.

SILVER SPRING, Md., July 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved 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.

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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. This medicine is also used to prevent blood clots in patients confined to bed and also for patients experiencing chest pain and heart attacks.

According to the National Heart, Lung, and Blood Institute, at least 100,000 cases of pulmonary embolism occur each year in the United States. It is the third most common cause of death among hospitalized patients.

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. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

For more information, including the FDA's response to the citizen petition

Enoxaparin Sodium for Injection

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220018.htm

Generic Drugs

http://www.fda.gov/Drugs/ResourcesForYou/ucm167906.htm

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
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