Posted by Michael Wonder on 09 Aug 2018
Glenmark Pharmaceuticals announces FDA acceptance of the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
7 August 2018 - The PDUFA target action date for completion of the FDA review is 21 March 2019.
Glenmark Pharmaceuticals today announced that the U.S. FDA 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 in patients 12 years of age and older.
Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.
