January 21, 2022

Glenmark Specialty S.A. (Switzerland) receives NDA Approval by the United States Food and Drug Administration (FDA) for Ryaltris™ Nasal Spray for the Treatment of Symptoms of Seasonal Allergic Rhinitis in Adults and Pediatric Patients 12 Years of Age and Older

Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received 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 Mr. 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).

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