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Home Industry News Baxter announces FDA approval for Gelfoam Plus

Baxter announces FDA approval for Gelfoam Plus

20th December 2007

Baxter Healthcare has announced that its Gelfoam Plus Haemostasis Kit has received approval from the US Food and Drug Administration (FDA).

The haemostasis kit provides Pfizer’s Gelfoam brand plus Baxter’s Thrombin which together is indicated for the control of bleeding during surgical procedures.

Baxter and Pfizer have also agreed a marketing, supply and manufacturing agreement for Gelfoam Plus which sees Baxter take on the role of exclusive distributor while Pfizer provides the sterile Gelforam gelatine absorbable sponge.

Ron Lloyd, vice-president of Baxter’s BioTherapeutics and Regenerative Medicine business, expressed the company’s pleasure in receiving FDA approval and confirming the collaboration with Pfizer.

“This reflects our commitment to providing options for use in surgical procedures, providing our customers with convenience and potential cost savings by supplying two components in a single kit,” he indicated.

Pfizer’s senior director of US Diversified Products David J Engels suggested that the Gelfoam Plus would be well received in the surgical field as it would provide a practical solution for achieving haemostasis.

Earlier this month, Baxter announced the launch of new drug safety packaging designed for high alert treatments with the aim of reducing medication errors through the use of additional safeguards.

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