FDA Alerts
FDA: Don't Prescribe Rx Combos With Too Much Acetaminophen
FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.
FDA Limits Duration and Usage of Samsca
The US Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.
Ravicti for the Management of Urea Cycle Disorders Approved
The US Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.
Drug Approved for Gaucher Disease
The U.S. Food and Drug Administration approved Elelyso ( taliglucerase alfa ) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
FDA Approves New Drug for Cushing’s Syndrome
Korlym ( mifepristone ) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.