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Home Industry News Pfizer withdraws marketing application for dalbavancin

Pfizer withdraws marketing application for dalbavancin

15th September 2008

Pfizer has announced it has withdrawn its global marketing applications for dalbavancin in order to conduct a new trial of the compound.

The company has retracted its marketing authorisation application in Europe and the new drug application in the US following feedback from regulatory authorities.

Pfizer will now conduct an additional trial of the compound as a treatment for patients with complicated skin and skin structure infections caused by Gram-positive bacteria, including MRSA.

It is hoped this study will result in the generation of further clinical data to support future planned regulatory submissions for the medication.

Dr Mark Kunkel, glbal medical therapeutic area leader for anti-infectives and HIV at the company, said: “After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections.”

He added the drug represents a potentially important advance in treatment in this indication, with the firm being dedicated to ongoing research of dalbavancin in patients with these conditions.

In December 2007, Pfizer confirmed the US Food and Drug Administration had issued an approval for dalbavancin as a treatment for adult patients with complicated skin and skin structure infections.

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