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Sanofi-aventis continues case over Lovenox

Sanofi-aventis is to continue its legal battle against the US FDA in relation to a generic version of Lovenox, despite rejection for preliminary injunctive relief

Sanofi-aventis (S-A) has announced it will continue its legal battle against the US Food and Drug Administration (FDA) in relation to a generic version of its blood-clot drug Lovenox, despite the US District Court of Colombia denying S-A's request for preliminary injunctive relief against the FDA.

A federal judge has denied S-A's request to issue preliminary injunctive relief against the FDA, which would have prevented the sale of generic versions of the company's anticoagulant Lovenox (enoxaparin) until a final verdict is delivered in S-A's case against the FDA over whether the body should have issued an abbreviated new drug application (ANDA) to Sandoz and Momenta for a generic version of Lovenox in July.

However, in a statement, S-A said it would continue its case against the FDA without preliminary injunctive relief, believing it still has a case relating to the FDA's review process for complex pharmaceutical products.

According to S-A, Lovenox has a highly-complex biological make-up and its structure, pharmacological properties and clinical properties are highly dependent on the manufacturing process, making it very difficult to replicate.

President and CEO of Momenta, Craig Wheeler said: "We continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection ANDA, and are pleased that the Court re-affirmed the validity of the FDA's decision.

"Sandoz commenced shipping of enoxaparin sodium injection following the FDA's marketing approval of Sandoz's ANDA on July 23, 2010," Wheeler said.

26th August 2010

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