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FDA backs new formulation of Noxafil

Merck wins US approval for delayed-release version of anti-infective

Merck & Co has won US approval for a delayed release version of its anti-infective Noxafil (posaconazole).

The treatment is a 100mg formulation of the already-approved Noxafil, which comes at a 40mg dose.

The new formulation offers an improved treatment regimen, with patients to take a loading does of three tablets twice on the first day before a once-daily dose of three tablets.

This compares to the 40mg verison, which is dosed three times a day.

The approval from the Food and Drug Administration (FDA) for Noxafil delayed release covers the use of the drug to treat prophylaxis of invasive Aspergillus and Candida infections in patients who are aged 13 or over.

Specially, the indication is for people at risk of developing these infections as they have a weekend immune system, such as those who have received a hematopoietic stem cell transplant or those undergoing chemotherapy who have low white blood cell count.

Dr Daniel Couriel, professor of internal medicine and clinical programme director, adult blood and marrow transplantation program, University of Michigan Comprehensive Cancer Center said: “Posaconazole delayed-release tablets offer physicians a way to help protect these critically ill patients against invasive Aspergillus and Candida infections while they are in the hospital and once they return home.”

Article by
Thomas Meek

2nd December 2013

From: Sales



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