Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais.
Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA approval for Ryaltris.
Each unit of the aqueous suspension nasal spray contains 665 mcg of olopatadine hydrochloride, a histamine-1(H1)-receptor inhibitor, and 25 mcg of mometasone furoate, a corticosteroid. The recommended daily dose for Ryaltris is two sprays in each nostril twice daily.
Ryaltris holds approval in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the UK and Uzbekistan. Hikma Specialty U.S.A. will market and distribute Ryaltris in the U.S. as part of an exclusive licensing agreement with Glenmark Specialty S.A.
“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,” Glenmark Pharmaceuticals CCO Robert Crockart said in a news release. “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.”