Glenmark Pharmaceuticals announced that it has received FDA approval of its NDA for Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older. The FDA accepted the NDA for Ryaltris in August 2018 and issued a CRL to the application in June 2019. Since that time, Ryaltris has been approved in much of the rest of the world, including the UK, the EU, Australia, and Russia.
Glenmark Pharmaceuticals Limited Chief Commercial Officer Robert Crockart commented, “The FDA’s approval of Ryaltris represents a major milestone for Glenmark and clearly supports our efforts to bring innovative treatment options in our key therapeutic areas. With this NDA approval, we look forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.”
Hikma Specialty USA will market Ryaltris in the US. Seqirus currently markets the nasal spray in Australia. Menarini acquired rights to Ryaltris for 33 European countries in December 2020, and Bausch Health acquired Canadian rights to the nasal spray in March 2021. In Asia, Glenmark is partnered with Grand Pharmaceutical in China and Yuhan Corporation in South Korea.
Read the Glenmark Pharmaceuticals press release.
