A court on Aug. 26 has denied Sanofi-Avnetis’ request for preliminary injunctive relief against the the FDA's approval of Sandoz Pharmaceuticals’ generic version of enoxaparin sodium injection (Lovenox),
The suit, filed July 27 with the U.S. District Court for the District of Columbia, urged the FDA to revoke Sandoz’ approved abbreviated new drug application (ANDA) after Sandoz was not reportedly required to provide additional data on the generic drug's safety and effectiveness.
Lovenox is an injection indicated to prevent deep vein thrombosis and for the prevention of complications linked to unstable angina and MI when administered with aspirin.
In a press release, the Paris-based Sanofi said, “The case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.”
Because the court has not yet ruled on the case, the generic form of Lovenox will continued to be sold and administered on the U.S. market.
"We continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection ANDA, and are pleased that the court re-affirmed the validity of the FDA's decision," stated Craig Wheeler, president and CEO of Momenta Pharmaceuticals, a partner of Sandoz. "Sandoz commenced shipping of enoxaparin sodium injection following the FDA's marketing approval of Sandoz' ANDA on July 23."
Sanofi said that the case will continue despite the court’s refusal to grant the preliminary injunctive relief.