Questions Regarding Deflazacort Access and Regulatory Status
This informational webinar highlighted the regulatory process to date, updated the community on Marathon Pharmaceutical’s Expanded Access Program (EAP) for deflazacort and discussed what a potential FDA approval of deflazacort would mean in terms of access to the drug in the United States. Some of those who import versions of deflazacort from abroad may have received an update from their distributor with initial details, which was discussed along with steps deflazacort patients might choose to take to help ensure continued access to U.S. supply of deflazacort if FDA approval is granted.
Marathon submitted New Drug Applications (NDAs) to the FDA for deflazacort (tablet form and oral suspension). The NDAs were accepted for filing in early August 2016, and FDA expects to complete its review of the applications in February 2017. Of note, Deflazacort is an investigational drug and is not currently approved as safe or effective for any use in the United States by the FDA.
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