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news.Arpida has reported that the rolling submission of the new drug application or NDA for intravenous iclaprim in its first indication, complicated skin and skin structure infections will be completed within the next few weeks.
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Arpida has agreed with the FDA to file the NDA in a rolling process. Using a ‘rolling NDA’ allows modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Both the rolling NDA and the electronic format could potentially facilitate the review process.
Khalid Islam, president and CEO of Arpida, said: “Completing the submission of the NDA as soon as possible, while at the same time maintaining high standards of quality, remains our highest priority. Unfortunately, some of the data to be included in the NDA package were delivered later than anticipated. These delays were amplified by the additional processing steps that need to be taken for the electronic format in which we are filing.”