The FDA has told IntelGenx (IGXT) and RedHill Biopharma (RDHL -2.8%) that it won't yet approve their VersaFilm oral film treatment for acute migraines, due to issues over third party manufacturing, packaging and labeling.
However, in a complete response letter, the FDA said it accepted the bioequivalence study and safety information submitted, and that it requires no additional studies.
IntelGenx and RedHill intend to address the FDA's concerns within weeks, and to advance discussion with potential partners for the commercialization of VersaFilm.
In addition to seeking FDA approval for the product, IntelGenx and RedHill intend to file for European authorization later this year. (PR)