The FDA has accepted Glenmark Pharmaceuticals’ NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019, the company said. Glenmark announced submission of the NDA in May 2018.
Positive results from Phase 3 studies of Ryaltris (formerly GSP 301) were announced in March 2017 and in December of that year.
Glenmark Pharmaceuticals President and Chief Medical Officer Fred Grossman said, “We are pleased that Glenmark’s rigorous study of Ryaltris led to today’s filing acceptance by the FDA. We look forward to offering a potential new treatment option for people suffering from seasonal allergic rhinitis.”
Read the Glenmark Pharmaceuticals press release.
