Eight drugs and medical devices approved by the FDA since May 4:
- FDA approves drug to treat rare nervous system disease
The FDA approved Viela Bio's Uplizna, designed to treat neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. - FDA approves antibiotic to treat hospital-acquired bacterial infection
The FDA approved Merck's Recarbrio, an antibiotic designed to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults. - FDA approves sedative for ventilator use
The FDA approved Gland Pharma's dexmedetomidine hydrochloride, a sedative designed to help intubate patients to be placed on a mechanical ventilator. - FDA approves first US drug to treat severe malaria
The FDA approved Amivas' artesunate for injection, designed to treat severe malaria in adults and children. - FDA approves first drug for pediatric bladder disorder
The FDA approved Astellas Pharma's VESIcare, designed to treat a form of bladder dysfunction related to neurological impairment in children ages 2 years and older. - FDA approves muscle relaxant drug for ventilator use
The FDA approved Nivagen Pharmaceuticals' succinylcholine chloride injection, designed to provide skeletal muscle relaxation during surgery or ventilation. - FDA approves Philips defibrillator device
The FDA approved Philips Medical Systems' HeartStart FRx Defibrillator, a battery-powered automated external defibrillator designed to treat sudden cardiac arrest. - FDA approves abdominal stent-graft device
The FDA approved Bolton Medical's Treo Abdominal Stent-Graft System, designed to repair an aneurysm of the abdominal aorta.