Rx UPDATE
August
2010
FDA Approves Generic Enoxaparin Sodium Injection
On July 23, 2010, the U.S. Food and Drug Administration (FDA) announced that the generic version of
Lovenox, enoxaparin sodium injection, is now available. Enoxaparin belongs to a class of medications
known as low molecular weight heparins (LMWH) and is used to prevent blood clots in deep veins such as in
the thigh or lower leg. The medication is also used to prevent blood clots in patients suffering a heart attack
or chest pain, following hip or knee replacement, or those confined to bed.
Sandoz, in conjunction with Momenta Pharmaceuticals, is the only manufacturer of generic enoxaparin
sodium injection at this time. Upon approval by the FDA, the company immediately began shipment of its
product to pharmacies.
In response, Sanofi-Aventis, the manufacturer of brand-name Lovenox, filed a lawsuit in federal court
requesting that the FDA suspend and withdraw its approval of the generic product. The lawsuit charged
the agency with exceeding its authority and acting arbitrarily and capriciously in granting approval for
the production and distribution of generic enoxaparin sodium injection. Sanofi-Aventis is disputing that
the generic version is not similar to Lovenox in safety and efficacy and therefore requested a temporary
restraining order that would force the FDA to withdraw the approval of the Momenta/Sandoz generic product.
On August 25, 2010, a U.S. District Judge denied the requested injunction. As a result, generic enoxaparin
sodium injection will continue to be marketed in the U.S. Sanofi-Aventis plans to continue to make Lovenox
available to health care professionals for their patients pending a final decision on the merits of the underlying
complaint.
Generic enoxaparin sodium injection is currently available in pharmacies. Sandoz is confident that there is
sufficient supply to meet demand and does not anticipate any shortages.
What Does this Mean for Members?
Members should continue to use their prescribed medication as directed by their health care provider.
Members will still be able to fill prescriptions for brand-name Lovenox; however, many will be switched to
generic enoxaparin sodium injection which the FDA has determined to be equivalent to the brand. Members
should discuss any concerns they may have with their physician but should not be concerned if they receive
generic enoxaparin sodium injection at the pharmacy.
What Does this Mean for Health Care Providers?
Providers will be able to continue their patients on their current prescribed therapy. Many patients will
be switched to generic enoxaparin sodium injection, but this should not impact their anticoagulation
therapy. Providers should monitor their patients as they normally would to ensure appropriate dosing and
anticoagulation.
As part of our pharmacy benefit management services, Catalyst Rx partners with clients, members,
physicians, and pharmacies to provide updates regarding medication safety issues, industry news and changes
to product availability. Catalyst Rx will continue to carefully monitor the situation and provide updates as
appropriate. If you have questions, please call the Catalyst Rx Market Intelligence Department at
702-869-4600.
References:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm
http://www.reuters.com/article/idUSLDE67P1JJ20100826
http://www.bloomberg.com/news/2010-08-26/sanofi-s-request-for-generic-lovenox-to-beblocked-denied-byu-s-judge.html
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