July 23rd, 2010
FDA Approves Generic Enoxaparin
Larry Husten, PHD
The FDA announced on Friday that it had approved the first generic enoxaparin sodium injection for multiple indications including prevention of deep vein thrombosis (DVT). The action represents the FDA’s first generic approval of a low molecular weight heparin. The original version of enoxaparin, Lovenox, was first approved in 1993. To gain approval as a generic, the FDA required its manufacturer, Sandoz, to perform “a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said an FDA official in a press release. More information about the approval is available on the FDA website.
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