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Biopharmaceutical company, Arpida Ltd has announced that it has received notice from the FDA advising that the agency’s Anti-Infective Advisory Committee will be discussing the possibility of a New Drug Application for intravenous iclaprim.
The discussions will take place during the company meeting between 18–20 November and, if a NDA is successful, it will allow for the use of intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI).
Marketing applications for intravenous iclaprim have already been filed for marketing in the USA, Canada and the European Union.
Iclaprim is a hospital antibiotic drug candidate with potent bactericidal activity against MRSA and an extended range of important pathogens.
Dr Paul Hadvary, Head of Development at Arpida Ltd, said: “We are delighted to have a opportunity to present iclaprim to leading experts in the anti-infective field and to discuss important features of our NDA with the Advisory Committee.”