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Judge denies request for enoxaparin injunction

August 27, 2010 12:54 AM UTC

A district court judge denied a request by sanofi-aventis Group (Euronext:SAN; NYSE:SNY) seeking a preliminary injunction that would have directed FDA to withdraw approval of a generic version of anticoagulant Lovenox enoxaparin from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and Momenta Pharmaceuticals Inc. (NASDAQ:MNTA). In his opinion, Judge Emmet Sullivan of the U.S. District Court for the District of Columbia said sanofi's argument was unlikely to succeed on its merits and that any claim the pharma made of irreparable harm from generic competition was "a wash" against harm to Sandoz from not being able to market its product.

Sullivan also said that because the court found that sanofi is unlikely to establish that FDA exceeded its authority in approving the ANDA, "the Court concludes that the public would be harmed by a court-ordered delay in the distribution of a generic drug that is approximately 30-35% cheaper than Lovenox." He added that no parties have challenged the safety of the generic. Sullivan also said that the court "must defer to the FDA's interpretation of the FDCA [Food, Drug, and Cosmetic Act] as long as it is reasonable." ...