Tag Archives: pediatric

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult… Read More: FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status… »

FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

TUESDAY, April 14, 2020 — Koselugo (selumetinib) has received the first approval for treatment of neurofibromatosis type 1 (NF1) in children ages 2 years and older, the U.S. Food and Drug Administration announced Friday. Approved specifically for patients with symptomatic, inoperable plexiform neurofibromas (PNs), Koselugo, a kinase inhibitor, works by blocking a key enzyme to… Read More: FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1 »

Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

TUESDAY, Oct. 1, 2019 — Rituxan (rituximab) injection was granted the first approval for a drug to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in combination with glucocorticoids in children 2 years and older, the U.S. Food and Drug Administration announced Friday. The agency noted that pediatric patients with GPA, previously known as… Read More: Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases »