Nycomed and Baxter win regulatory approval for TachoSil

Nycomed and Baxter have had their surgical patch product TachoSil ratified by the Food and Drug Administration.

The regulator granted approval to the haemostasis product on the basis of positive findings from clinical trials, which showed its potential applications in controlling bleeding during cardiovascular surgery.

As a result of this approval, the product, which is the central offering in Nycomed’s tissue management range, can now be used as an adjunct to haemostasis in procedures of this kind.

This comes after TachoSil’s successful European launch, leading Nycomed to state that it continues to have “great expectations” for the patch.

Guido Oelkers, Nycomed’s executive vice-president of commercial operations, hailed the contribution of its partner Baxter in the product’s development, stating: “TachoSil perfectly complements Baxter BioSurgery’s portfolio of surgical products.”

Last month, the company published its financial results for 2009, during which the firm saw growth in its key product ranges despite a decline in net turnover.