Glenmark Pharma arm secures USFDA nod for Ryaltris nasal spray
Mumbai: Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received US Food and Drug Administration (USFDA) 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 recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily.
"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). Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan.
Read also: Glenmark gets marketing approval for Ryaltris in 13 EU, UK countries
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.
