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sanofi sues FDA over generic approval

July 27, 2010 11:46 PM UTC

sanofi-aventis Group (Euronext:SAN; NYSE:SNY) filed suit in the U.S. District Court for the District of Columbia seeking a temporary restraining order and a preliminary injunction requiring FDA withdraw Friday's approval of a generic version of marketed anticoagulant Lovenox enoxaparin. In its complaint, sanofi alleges that by approving the generic, FDA exceeded its authority, ignored its own precedent regarding approval of generic versions of drugs that have not been fully characterized, and failed to ensure that Sandoz's drug has the same active ingredient as Lovenox.

FDA and agency Commissioner Margaret Hamburg are named as defendants in the suit, along with HHS Secretary Kathleen Sebelius. The court set a deadline of Aug. 4 for the defendants to respond to the complaint, with a hearing planned for Aug. 17. ...