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news.Sanofi-aventis has raised concern over the implications for patient safety, since the FDA approval of another version of enoxaparin sodium has not been subjected to extensive clinical trials to demonstrate its efficacy and safety as Sanofi-aventis has done with its product Lovenox (enoxaparin sodium).
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Sanofi-aventis said that Lovenox, by nature, is a complex biological product and its efficacy and safety profile relies on the strict adherence to the specific processes applied in its manufacturing as well as its traceability from the animal mucosa to the finished product.
Sanofi-aventis stated that it has been in regular communication with the FDA since the 1980’s on the quality standards of Enoxaparin sodium and most recently through a Citizen’s Petition to share the company knowledge on heparins.
However, the FDA-approved version has not been evaluated on the basis of an extensive clinical program showing proven and comparable clinical efficacy and safety to Lovenox.
Sanofi-aventis is expected to avail itself of appropriate analytical and clinical avenues to assess the quality, efficacy and safety of the product and is considering all appropriate legal options.
Sanofi-aventis added that it makes healthcare professionals aware of the complexities related to the biologic composition and manufacturing of Low Molecular Weight Heparins and Lovenox.