Glenmark gains US approval for Ryaltris nasal spray

Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296) says it has received approval from the US Food and Drug Administration on its New Drug Application (NDA) for Ryaltris (olopatadine Hcl and mometasone furoate), an innovative, fixed dose (metered), prescription, combination drug product nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older in the USA.

“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, adding: “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.”

Ryaltris has not had an easy path to approval in the USA. In 2019, the FDA issued a complete response letter (CRL), citing deficiencies in the Drug Master File (DMF) relating to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities.