US Food & Drug Administration (USFDA) has accepted to review the New Drug Application (NDA) of Glenmark Pharmaceuticals’ 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 [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. The filing for Ryaltris includes efficacy and safety results from two pivotal, randomized, multicenter, double-blind, placebo-controlled trials in adults and adolescents 12 years of age and older with SAR.
Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).
