MUMBAI, India and MAHWAH, N.J., Jan. 14, 2022 /PRNewswire/ -- 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 Ryaltristm, 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 Ryaltristm 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."
Ryaltristm 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).
About Ryaltristm
Ryaltristm 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. Each unit of Ryaltristm nasal spray contains 665 mcg of olopatadine hydrochloride, a histamine-1(H1)-receptor inhibitor, and 25 mcg of mometasone furoate, a corticosteroid. 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. The safety and effectiveness of Ryaltristm in pediatric patients younger than 12 years of age has not been established.
The recommended daily dose for Ryaltristm is 2 sprays in each nostril twice daily.
Ryaltristm will be marketed and distributed in the United States through our partner Hikma Specialty U.S.A. Inc., Columbus, OH.
Ryaltristm 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.
Glenmark has entered into commercial agreements with several partners around the world, including Menarini for the commercialization of Ryaltristm in select EU markets, and with Bausch Health in Canada (where it is under review by Health Canada).
U.S. Important Safety Information for Ryaltristm
For full prescribing information, please write to [email protected].
About Glenmark Pharmaceuticals Limited (Mumbai, India)
Glenmark Pharmaceuticals Limited (Glenmark) is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 80 countries. Glenmark's key therapeutic areas of focus are respiratory, dermatology and oncology. It ranks among the world's top 50 Generics and Biosimilar companies (Top 50 Company Rankings, 2020, from Informa's Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry being featured in the index. For more information, visit www.glenmarkpharma.com.
SOURCE Glenmark Pharmaceuticals Ltd
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