Glenmark Pharmaceuticals Limited, announced the FDA approval of 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 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 Ryaltris™ 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 Ryaltris™ in pediatric patients younger than 12 years of age has not been established.
The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily.
Ryaltris will be marketed and distributed in the United States through their partner Hikma Specialty U.S.A. Inc., Columbus, OH.
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.
Glenmark has entered into commercial agreements with several partners around the world, including Menarini for the commercialization of Ryaltris™ in select EU markets, and with Bausch Health in Canada (where it is under review by Health Canada).
https://en.wikipedia.org/wiki/Mometasone
https://en.wikipedia.org/wiki/Olopatadine
FDA Approves Ryaltris (mometasone and olopatadine) Nasal Spray for Seasonal Allergic Rhinitis
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