Glenmark Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market Ryaltris, a nasal spray for the treatment of seasonal allergic rhinitis.
The company's fully-owned unit Glenmark Specialty SA (Switzerland) has received approval from the USFDA for its new drug application (NDA) for Ryaltris, a fixed-dose (metered), prescription, combination nasal spray, Glenmark Pharmaceuticals said in a statement.
The product is used for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older, it added.
“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, the company looks 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, he added.
Ryaltris will be marketed and distributed in the United States by Hikma Specialty USA, Inc, as part of its exclusive licensing agreement with Glenmark Specialty SA.
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 regulatory procedure in Europe, enabling approval in 17 countries across the EU and UK.
The drug firm has entered into commercial agreements with several partners around the world, including Menarini for the commercialisation of the drug in select EU markets and with Bausch Health in Canada.
The product is under review by Health Canada.