Safety Alerts & Recalls

What does this mean?

The FDA has approved the Sandoz/Momenta generic enoxaparin and determined it can be automatically substituted for Lovenox at the pharmacy. There are no special guidelines for additional monitoring required. If you have questions or concerns about the generic approval of enoxaparin, please follow up with your doctor, pharmacist, or other healthcare professional.

Please note, it often takes some time after the FDA approval before the generic is available in pharmacies, hospitals, and clinics. Information about the marketing and availability of this generic drug can be obtained from the manufacturers, Sandoz, Inc, and Momenta Pharmaceuticals, Inc.

FDA Publishes Question and Answers about Approval of Generic Version of Lovenox (Enoxaparin Sodium Injection)

Today the U.S. Food and Drug Administration (FDA) announced the approval of the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant medicine used to prevent deep vein thrombosis (DVT), a blood clotting condition of the legs. The approval was given to the manufacturer Sandoz, Inc, in partnership with Momenta Pharmaceuticals.

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. Prior to the approval, the FDA received a Citizen petition questioning the approval criteria for generic enoxaparin sodium injection. There were concerns that the manufacturing process can be more complex for a natural product such as enoxaparin.

To answer some of the questions and concerns about the approval of the generic enoxaparin, the FDA has published a web page titled "Generic Enoxaparin Questions and Answers. To view the FDA's web page about generic enoxaparin, please visit: more information here

To view additional information about generic enoxaparin from the FDA, please visit: more information here and

more information here

Source: FDA
Publication Date: 2010-07-23
Last Updated: 2010-07-23
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