Enoxaparin regulatory update

FDA approved an ANDA for a generic version of marketed anticoagulant Lovenox enoxaparin, a low-molecular weight heparin from sanofi-aventis Group (Euronext:SAN; NYSE:SNY, Paris, France). Momenta and partner Sandoz, the generics unit of Novartis, originally submitted the ANDA in 2005. The partners received a not approvable letter in 2007. Sandoz began shipping the product, which can be substituted for Lovenox.

FDA also issued a report in response to a 2003 Citizen's Petition from sanofi asking the agency not to approve any enoxaparin generics. In the response, FDA asserted that its current scientific evidence, precedent and legal authority establish a "sound basis" for the approval of generic enoxaparin. sanofi said in a statement that it is "concerned" for patient safety and plans to assess the quality, efficacy and safety of the generic. sanofi also said it is considering legal options. Lovenox had 2009 sales in the U.S. of €443 million ($638.4 million). ...