Glenmark Pharmaceuticals announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received U.S. FDA approval on its New Drug Application (NDA) 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 Pharmaceuticals Limited. "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."

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

Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan. In April 2021, Glenmark concluded the DCP regulatory procedure in Europe, enabling approval in 17 countries across EU and UK.