According to Glenmark, the drug is for rhinitis in adults and paediatric patients 12 years of age and older in the US.
"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 Chief Commercial Officer Robert Crockart.
Ryaltris will be marketed and distributed in America by Hikma Specialty U.S.A., Inc., as part of its exclusive licensing agreement with Glenmark Specialty S.A.
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Glenmark has entered into commercial agreements with several partners around the world, including Menarini for the commercialisation of Ryaltris in select EU markets, and with Bausch Health in Canada (where it is under review by Health Canada), the company said.