Glenmark Pharmaceuticals, a global pharmaceutical company, 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 (SAR) in patients 12 years of age and older.…
The FDA Approves First Supplemental Abbreviated New Drug Application For Manufacturing Facility
The FDA provided its first supplemental Abbreviated New Drug Application (sANDA) to Glenmark Pharmaceuticals for the company’s manufacturing facility in Monroe, North Carolina. The approval covers: Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline’s Malarone (atovaquone and proguanil hydrochloride) Tablets. “This approval is an important milestone for our U.S.…