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REINACH, Switzerland, October 14 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI) during its meeting on 18-20 November 2008. An Advisory Committee can be requested by FDA as part of the review process of an NDA or supplemental NDA.
Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens. To date, Arpida has filed marketing applications for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections in the U.S.A., Canada and the European Union.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are delighted to have an opportunity to present iclaprim to leading experts in the anti-infective field and to discuss important features of our NDA with the Advisory Committee."
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company headquartered in Reinach, Switzerland with operations in Switzerland and the USA. It focuses on the discovery, development and commercialisation of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial under regulatory review and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent
antibacterial that targets severe infections requiring hospital treatment,
including those caused by methicillin-resistant Staphylococcus aureus
(MRSA). The clinical programme for the first indication, complicated skin
and skin structure infections (cSSSI), has been completed. The submission
of the NDA to the US FDA was completed in March 2008. The FDA has defined
that the Prescription
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