FDA approval for new Eloxatin formulation
PARIS, FRANCE, February 3, 2005 -- The Sanofi-Aventis Group
announced that it 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, colorless 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.
Eloxatin received approval in France for the second-line treatment of metastatic colorectal cancer in April 1996, and as a first-line treatment in April 1998. In July 1999, Eloxatin(R) was approved for the first-line treatment of advanced colorectal cancer in major European countries through the Mutual Recognition Procedure, France being the Reference Member State.
Eloxatin successfully completed a Mutual Recognition Procedure in Europe in December 2003, which allowed the product to be marketed for the treatment of metastatic colorectal cancer in combination with 5-fluorouracil and folinic acid (i.e., in first- and second-line treatment). In September 2004, the indication for Eloxatin was extended in Europe, again through the Mutual Recognition Procedure, to include the "Adjuvant treatment of stage III (Dukes' C) colon cancer after complete resection of primary tumor."
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 tumor.
An extensive worldwide clinical development program is ongoing to explore the potential benefits of Eloxatin (oxaliplatin Injection) in other types of cancer.
Full prescribing information, including clinical trial
information, safety, dosing, drug-drug interactions, and
contraindications, is available at: www.fda.gov/cder/foi/label/2004/021492s004lbl.pdf.
Source: Sanofi-Aventis
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