Tag Archives: Injection

Injectafer (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia

BASKING RIDGE, N.J. and SHIRLEY, N.Y., May 6, 2021 /PRNewswire/ — Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult… Read More »

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent Print this page Houston, TX and St. Louis, MO, Sept. 08, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA).  Detectnet… Read More »

Viltepso (viltolarsen) Injection Granted Accelerated Approval for Rare Duchenne Muscular Dystrophy Mutation

News Consumer News Viltepso (viltolarsen) Injection Granted Accelerated Approval for Rare Duchenne Muscular Dystrophy Mutation THURSDAY, Aug. 13, 2020 — Accelerated approval has been granted to Viltepso (viltolarsen) injection for treatment of patients with Duchenne muscular dystrophy (DMD) and a mutation of the DMD gene amenable to exon 53 skipping, the U.S. Food and Drug… Read More »

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »

FDA Approves Myobloc (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

Print this page LOUISVILLE, Ky., Aug. 26, 2019 /PRNewswire/ — US WorldMeds, LLC announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Myobloc (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults.1  Sialorrhea, or drooling, is defined as an excess spillage of saliva out of… Read More »