The sanofi-aventis Group has received marketing approval from the United States Food and Drug Administration for a new aqueous solution formulation of Eloxatin (oxaliplatin injection).
This new formulation, Eloxatin (oxaliplatin injection) Injection, is a clear, preservative-free, colourless solution, which does not require reconstitution prior to dilution and administration.
Eloxatin Injection offers additional convenience to physicians and nurses since it involves fewer steps in the administration of Eloxatin, a company release said.
In the United States, Eloxatin, in combination with infusional 5-FU/LV, received approval on January 9, 2004, for the first-line treatment of advanced carcinoma of the colon or rectum (i.e., first therapy for patients with metastatic colorectal cancer). This same Eloxatin-based combination had initially (August 2002) received FDA approval for second-line treatment, (i.e., therapy for previously treated patients with metastatic colorectal cancer).
On November 4, 2004, this Eloxatin-based regimen was approved for the adjuvant treatment of stage III (Dukes' C) colon cancer after complete resection of the primary tumour.
Eloxatin was developed in association with Debiopharm SA and is currently marketed by sanofi-aventis in more than 60 countries.