Glenmark's arm receives NDA Approval by US FDA for Ryaltris Nasal Spray

Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced that its 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.

"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.

Ryaltris is a metered, fixed-dose, aqueous suspension, prescription drug product nasal spray approved by the FDA for the treatment of symptoms associated with Seasonal Allergic Rhinitis.

The combination drug product nasal spray is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older.

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The safety and effectiveness of Ryaltris in pediatric patients younger than 12 years of age has not been established.

Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan.

(With inputs from ANI)