New Delhi: 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 brand name, the company added.
Glenmark said it expects the USFDA will determine whether the NDA is complete for filing within 60 days.
“If the NDA is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time,” it added.
Glenmark has studied Ryaltris in seven clinical trials involving more than 4,000 patients.