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Glenmark Pharmaceuticals has submitted a new drug application with the US health regulator for its nasal spray Ryaltris, used for the treatment of seasonal allergic rhinitis (SAR) in patients of 12 years and above.
“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 today.
Ryaltris in used in seven clinical trials involving more than 4,000 patients. Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)), formerly GSP 301 nasal spray, have been conditionally accepted by the USFDA as the brand name, the company added.
Glenmark said it expects the USFDA will determine whether the new drug application is complete for filing within 60 days. “If the new drug application is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time,” it added.
Shares of Glenmark Pharmaceuticals were trading 0.36 per cent higher at Rs 502.65 on the BSE.
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