RedHill Biopharma - FDA accepts TALICIA’s NDA
On 3 July 2019, RedHill announced that the FDA has accepted for review the new drug application (NDA) for TALICIA for the treatment of Helicobacter pylori infection. As TALICIA is a designated Qualified Infectious Disease Product (QIDP), the FDA also granted a priority review, which will shorten the usual review time from the standard 10 months to six months. As a result, 2 November 2019 was set as the target Prescription Drug User Fee Act (PDUFA) date. Based on the data released, we assign a high likelihood of FDA approval due to the clean dataset from the Phase III trials. If approved, TALICIA could be launched by end 2019.
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