FDA accepts Ryaltris NDA for review

India-headquartered Glenmark Pharmaceuticals (BSE: 532296) today announced that the US Food and Drug Administration has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.

In Wednesday’s trading, Glenmark’s shares opened at 505.05 rupees and at 11:13 am, the stock was quoting 586.75 rupees per share, a rise if around 16%.