Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA […]
Glenmark Pharmaceuticals
Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide. The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm. “Respiratory is a core […]
Glenmark, Evestra ink deal to develop generic NuvaRing
Glenmark Pharmaceuticals and Evestra said today that the companies inked a development, license and commercialization deal for a generic version of Merck’s NuvaRing. Development of the etonogestrel/ethinyl estradiol contraceptive is under way, according to the companies, and they plan to file an Abbreviated New Drug Application in fiscal 2019. “This is an important U.S.-based strategic partnership […]
