Glenmark Pharmaceuticals has submitted a new drug application with the US health regulator for its nasal spray Ryaltris.
Ryaltris is for treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
"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," Glenmark Pharmaceuticals said in a BSE filing.
Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)), formerly GSP 301 Nasal Spray, has been conditionally accepted by the USFDA as the