Drug maker Sanofi-Aventis has expressed concern over the approval of generic versions of its blood-thinning medication, Lovenox.
The US Food and Drug Administration (FDA) recently approved generic versions of Lovenox (enoxaparin sodium), which is used to treat deep vein thrombosis among other conditions.
Sanofi-Aventis has reservations over safety checks that rival medications have undergone, stating that the drugs have not been subjected to the same clinical trials that Lovenox has.
Job Harenberg, MD, professor of medicine at the University of Heidelberg, said that there are significant challenges in demonstrating therapeutic equivalence of biological products similar to enoxaparin without direct, comparative trials.
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