The US Food and Drug Administration (FDA) has approved a prescription nasal spray for seasonal allergic rhinitis. Mometasone furoate monohydrate (Ryaltris) is approved for adults and pediatric patients aged 12 and older.
The medication is manufactured by the Glenmark Specialty SA, a Swiss subsidiary of Glenmark Pharmaceuticals Limited, headquartered in Mumbai, India.
“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, the chief commercial officer of Glenmark Pharmaceuticals, in a press release. “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.”
Each unit of the metered nasal spray contains 665 μg of olopatadine hydrochloride and 25 μg of mometasone furoate. The recommended dose is two sprays per each nostril, twice daily. The most common side effects are unpleasant taste, nose bleeds, and nasal discomfort. Patients with a weakened immune system taking Ryaltris require close medical supervision, as there is an increased risk of occurrence or worsening of preexisting infections. Close growth monitoring for pediatric patients aged 12 and older is also recommended.
Ryaltris has already been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan. The nasal spray is current under review by Health Canada.
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