Tag Archives: approves

FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture

FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture Print this page April 9, 2019 — The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of… Read More »

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD Print this page STAMFORD, Conn.–(BUSINESS WIRE) March 01, 2019 –Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for… Read More »

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »