Stephen B. Shohet, MD

A year ago, I was asked by a small pharmaceutical company in Southern California to compare the biochemical characteristics of their generic low-molecular weight heparin enoxaparin to Lovenox, the FDA-approved proprietary product manufactured by Sanofi-Aventis. For that review, I considered a large amount of data provided to the FDA as part of a long-standing application for approval of the generic product. Among other things, I found that the polysaccharide chain lengths, the anion distributions, the sulfate ion concentrations, the number of 1,6 anhydro rings, and the sugar epimer distributions were all identical in the proprietary and generic preparations.