The US Food and Drug Administration (FDA) has approved a prescription nasal spray for seasonal allergic rhinitis. Mometasone furoate monohydrate (Ryaltris), is approved for both adults and children 12 and above.
The medication is manufactured by Glenmark Specialty SA, a Swiss subsidiary of Glenmark Pharmaceuticals Limited, headquartered in Mumbai, India.
“The FDA’s approval of Ryaltris represents a major achievement for Glenmark and is a clear endorsement of our efforts to develop new treatment options to our key therapeutic areas,” said Robert Crockart who is the chief commercial officer of Glenmark Pharmaceuticals, in a press release. “With this NDA approval, we look at bringing this exciting medicine to physicians and their patients to treat symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.”
Each nasal spray is metered and includes 665 mg of olopatadine hydrochloride and 25 mg mometasone furoate. The recommended dose is two sprays per each nostril twice per day. The most common side effects are unpleasant taste, nose bleeding and nasal discomfort. Patients who have weak immune systems must be closely monitored by a doctor before Ryaltris is administered. There is a higher chance of developing or worsening preexisting infections. Children 12 years old and older should be monitored for growth.
Ryaltris has already been approved and is being sold in Australia and the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan. The nasal spray is currently under review by Health Canada.
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