Glenmark Specialty S.A. receives FDA green light for Ryaltris

Glenmark Specialty S.A. (Switzerland), has received the Food and Drug Administration’s clearance for Ryaltris, an innovative, fixed-dose (metered), prescription, combination drug product nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States.

"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," said Robert Crockart, chief commercial officer of Glenmark. "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."

[Read more: Hikma, Glenmark ink licensing agreement for Ryaltis]

Ryaltris will be marketed and distributed by Hikma Specialty U.S.A., as part of its exclusive licensing agreement with Glenmark Specialty S.A (Switzerland).