Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.
(Updated April 13, 2017
The FDA has approved the following drugs:
The FDA has approved the following expanded indication:
- Austedo (deutetrabenazine) oral tablets for the treatment of chorea associated with Huntington disease. Prescribing information includes a Boxed Warning regarding depression and suicidality.
- Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) to treat hepatitis C virus (HCV) in pediatric patients 12 to 17 years of age which were previously approved only in adults. Prescribing information for both Sovaldi and Harvoni includes a Boxed Warning regarding hepatitis B virus reactivation.
- Ingrezza (valbenazine) oral capsules for the treatment of adults with tardive dyskinesia.
- BAT (botulism antitoxin heptavalent [A, B, C, D, E, F, G] [equine]) sterile solution for injection to treat symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adult and pediatric patients.
- Visipaque (iodixanol) 320 mg iodine/mL injection to include intravenous coronary CT angiography to assist in the diagnostic evaluation of patients with suspected coronary artery disease in adult and pediatric patients 12 years and older. Intravenous Visipaque is also indicated for computed tomography (CT) imaging of the head and body, excretory urography, and peripheral venography, and for CT imaging of the head and body and excretory urography in pediatric patients younger than 12 years of age. Intra-arterial Visipaque is indicated for digital subtraction angiography, angiocardiography, peripheral arteriography, visceral arteriography, and cerebral arteriography in adult and pediatric patients 12 years and older, and for angiocardiography, cerebral arteriography, and visceral arteriography in pediatric patients younger than 12 years of age. Visipaque is not for intrathecal use.