US Pharm. 2010;35(10):102.A federal judge refused to issue a temporary injunction halting sales of a generic version of the anticoagulant drug enoxaparin sodium injection (Lovenox), sought by the brand-name drug's maker Sanofi-Aventis. Sanofi-Aventis sued the FDA in August in an effort to reverse the agency's July 23 approval of a generic version of enoxaparin, made by Sandoz. Sanofi-Aventis alleged that the FDA had failed to ensure that the generic version of the drug made by Sandoz had the same active ingredient as enoxaparin; ignored its own precedent by approving a generic version of a drug not yet fully characterized; and exceeded its authority by breaking the rules for a so-called abbreviated new drug application. Sanofi-Aventis characterized the FDA's approval of the generic as capricious, arbitrary, and unlawful. Worldwide sales of Lovenox for Sanofi-Aventis were approximately $3.9 billion in 2009.
In an opinion issued on August 25, Judge Emmet Sullivan of the U.S. District Court in Washington, DC, declined to issue a temporary injunction directing the FDA to withdraw its approval of the generic drug. Judge Sullivan stated that Sanofi-Aventis was unlikely to demonstrate that the FDA had acted improperly, stating that “Just because the FDA...reached a conclusion at odds with the position advanced with Sanofi, does not mean that the FDA's decision was arbitrary and capricious.” The $2.5 billion in domestic sales of Sanofi-Aventis's generic Lovenox in 2009 amounted to 6% of the company's total revenue, he noted.