US FDA suspends generic oxaliplatin after legal action from Sanofi-Aventis

French drug major Sanofi-Aventis says that a US appeals court has suspended approvals of generic copies of its colorectal cancer treatment Eloxatin (oxaliplatin), delaying competition in the USA for one of its top-selling drugs, generic copies of which had been approved by the Food and Drug Administration from Israel's Teva, Indian-owned Sun Pharmaceutical Industries and the USA's Hospira. The drug generated sales of around $1.9 billion for Sanofi in 2008.

On August 14, Hospira said it received a notice from the FDA that the Abbreviated New Drug Application approval for its oxaliplatin products, approved just days earlier, has been suspended. The suspension is related to legal proceedings initiated by the innovator company against the FDA and a Court order issued in that proceeding. The suspension is temporary until such time as the Court has an opportunity to consider arguments on this matter to be filed by August 18, the US firm noted. The suspension is not related to the safety and efficacy of the product. The company has temporarily discontinued the shipment of any additional product to the market pending further developments.

Teva and Sun are now also stopped from selling the product, and the court ruling prevents the FDA from approving other demands for generic versions of Eloxatin.