Glenmark Files an Application to the USFDA for its Nasal Spray

May 22, 2018  Source: Ddu 126

The U.S Food and Drug Administration received a new drug application from Glenmark Pharmaceuticals for its nasal spray Ryaltris, which is used for the treatment of seasonal allergic rhinitis (SAR) for above the age of 12-years. Ryaltris is an investigational fixed-dose combination nasal spray for which Glenmark submitted an NDA new drug application to the USFDA

The company informed that 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.

In case the NDA accepts it, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned.

Glenmark’s conducted seven clinical trials using more than 4,000 patients to test the efficacy of Ryaltris.

By editor
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