Posted by Michael Wonder on 08 May 2019
RedHill Biopharma submits new drug application for Talicia for H. pylori Infection
7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, it has submitted a new drug application to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection.
The application was submitted under the 505(b)(2) regulatory pathway. Talicia was granted qualified infectious disease product designation by the FDA and is eligible for six month priority review of the NDA.
If approved, Talicia will receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.
