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Generic version of Lovenox rejected

The US Food and Drug Administration (FDA) has rejected a generic version of sanofi-aventis' blockbuster thrombosis drug Lovenox (enoxaparin)

The US Food and Drug Administration (FDA) has rejected a generic version of sanofi-aventis' blockbuster thrombosis drug Lovenox (enoxaparin). 

Momenta Pharmaceuticals announced that its collaboration partner Sandoz, a division of Novartis, had received a letter from the FDA stating that Sandoz' abbreviated new drug application (ANDA) for enoxaparin sodium injection is not approvable.

According to Momenta, the FDA's letter stated that the ANDA did not adequately address the potential effects of the drug on the immune system.  

The FDA recommended that Sandoz and Momenta meet with the Office of Generic Drugs to determine what additional information should be provided to adequately address this concern. 

The FDA has also stated that all applications for enoxaparin must address the potential for immunogenicity. 

"In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA's concerns, based on our detailed characterization of enoxaparin and on the current medical and scientific literature," said Craig A. Wheeler, President and Chief Executive Officer. "Our path forward will be determined in conjunction with Sandoz and the FDA."

The news has led to a drop in Momenta's shares, which opened 46 per cent lower on Nasdaq. 

Analysts from Citi Investment Research say the concerns don't appear to be over a lack of characterisation, so Momenta's version, which is likely to show bioequivalence, could still be approved in the future. 

Sanofi-aventis had global sales of EURO 1.94 bn in Q3 2007, and is the company's best-selling drug.

30th September 2008

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