Arpida Ltd announced that it has received notice from the US 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 cSSSI in the USA, 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."
Arpida is a biopharmaceutical company headquartered in Reinach, Switzerland with operations in Switzerland and the USA.