Tag Archives: Approves

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

Print this page March 5, 2019 — The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting… 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 Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A

FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A Print this page Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with hemophilia A. Esperoct is the brand name for… Read More »