Posted by Michael Wonder on 21 May 2018
Glenmark Pharmaceuticals announces the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
21 May 2018 - Glenmark Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA 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.
Glenmark has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Phase 3 results of Ryaltris have been previously presented at key medical meetings, most recently at the Joint Congress of the American Academy of Allergy, Asthma and Immunology and the World Allergy Organization held in March 2018.
