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Glenmark Pharma submits application for new drug Ryaltris with USFDA

Ryaltris is for treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older

Press Trust of India  |  New Delhi 

Pharmaceuticals, drugs, pharma industry, medical, health, lab

Glenmark Pharmaceuticals has submitted a new drug application with the US health regulator for its

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 of an antihistamine and a steroid," Glenmark Pharmaceuticals said in a BSE filing.

(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.

Shares of Glenmark Pharmaceuticals were trading 0.36 per cent higher at Rs 502.65 on BSE. PTI SVK ANS ANS

First Published: Tue, May 22 2018. 11:02 IST
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