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Home Industry News MSD receives priority status for Gardasil

MSD receives priority status for Gardasil

20th March 2008

A drug developed by Merck (MSD) has been granted with priority status, meaning it is a product addressing unmet needs within the medical sector.

MSD announced that Gardasil, a cervical cancer vaccine, has been designated priority review status in the US.

This indicates that the Food and Drug Administration (FDA) will aim to review and act on MSD’s application for the drug within six months.

The supplemental application in question is for Gardasil (Human Papillomavirus Quadrivalent) (Types 6, 11, 16, 18). It is for the potential use in women aged between 27 and 45.

MSD’s current offering of Gardasil is for use in girls and women aged between nine and 26, and works to prevent cervical cancer, genital warts and precancerous or dysplastic lesions caused by HPV.

Also sold in some countries as Silgard, the product is also approved in 27 European Union countries in addition to Canada, Australia, Taiwan and Brazil, among others.

Meanwhile, January saw MSD announce the approval of Emend (fosaprepitant dimeglumine) for injection.

The intravenous therapy was developed to prevent nausea and vomiting induced by chemotherapy.

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