US FDA approves first generic of Sanofi-Aventis' Lovenox for Sandoz, for DVT prevention

The US Food and Drug Administration delivered a blow to Sanofi-Aventis on Friday, when it approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a drug that had generated revenues of around $4.57 billion in (according to IMS Health) for the French drug major last year.

The approved generic application is for Swiss drug major Novartis's subsidiary Sandoz, which, with partner Momenta Pharmaceuticals, has been vying for five years with Amphastar Pharmaceuticals to be first to get a copy version of the blockbuster drug cleared in the USA. Israel's Teva is also looking to launch a generic of Lovenox.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.