Glenmark’s Ryaltris nasal spray receives approval from US FDA

Ryaltris will treat patients having symptoms of seasonal allergic rhinitis

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Glenmark Ryaltris nasal spray is used for the treatment of seasonal allergic rhinitis in adults
Glenmark’s Ryaltris nasal spray is used for the treatment of seasonal allergic rhinitis in adults

Aptar Pharma has announced that its VP3 multidose device is the delivery system for Glenmark’s Ryaltris nasal spray, which recently received New Drug Application (NDA) approval by the US Food and Drug Administration (FDA) for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older.

Using Aptar Pharma’s innovative VP3 nasal spray with a custom-designed reduced evaporation cap, Ryaltris is a metered, fixed-dose, aqueous suspension prescription combination drug product nasal spray that combines an antihistamine (Olopatadine) with a steroid (Mometasone Furoate) for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.

Glenmark is focusing on delivering the right treatment options

The effort to bring Ryaltris nasal spray to market was supported by a combination product documentation package from Aptar Pharma’s services offering, a comprehensive portfolio of stage-specific development packages. Aptar Pharma’s dedicated regulatory affairs professionals and analytical scientists help customers proactively address regulatory needs to accelerate approval.

“Glenmark’s constant focus is on delivering the right treatment options to the patients, using effective technology. Adapting Aptar Pharma’s innovative VP3 multidose device as the delivery system for our novel Ryaltris nasal spray is yet another effort in this regard,” said Robert Crockart, chief commercial officer, Glenmark Pharmaceuticals.

“This NDA approval by the US FDA for a combination drug product using our VP3 multidose nasal pump further demonstrates Aptar Pharma’s ability to help our customers develop and launch novel treatments,” stated Gael Touya, President, Aptar Pharma. “Our nasal systems’ proven capabilities bring added value to our customers and further convenience for patients worldwide.”

 

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