US FDA approves Glenmark’s NDA for ‘Ryaltris’ nasal spray
The US Food and Drug Administration has approved the new drug application (NDA) of Glenmark Specialty, the Swiss-subsidiary of Indian drug maker Glenmark Pharma, for Ryaltris, an innovative, fixed- dose (metered), prescription, combination of 665 mcg of olopatadine hydrochloride, a histamine-1(H1)-receptor inhibitor, and 25 mcg of mometasone furoate nasal spray for the treatment of symptoms of seasonal allergic rhinitis. The FDA approval indicates use of the spray in adults and pediatric patients 12 years of age and older. Ryaltris will be marketed and distributed in the US by Hikma Specialty USA, as part of its exclusive licensing agreement with Glenmark Specialty. Glanmar said in a statement that with this NDA approval, it looks 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.