Glenmark Pharmaceuticals has submitted a new drug application for its nasal spray Ryaltris, with the US health regulator.

In a BSE filing the company stated, “The company has submitted a new drug application (NDA) to the US Food & Drug Administration (USFDA) for… respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid.”

Ryaltris, is used for treating seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Further the company expects that, the USFDA will will determine whether the NDA is complete for filing within 60 days and if NDA is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time.

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