FDA Alerts
FDA Compares Risks of Pradaxa and Warfarin
FDA research has taken a closer look at the risks of two medications commonly used to lower the risk for stroke and blood clots.
FDA Approves Sylvant for Rare Castleman’s Disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
FDA Approves Alprolix for Patients With Hemophilia B
The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
FDA Approves Tretten for Rare Genetic Clotting Disorder
The US Food and Drug Administration (FDA) has approved a new medication to treat a rare clotting disorder in both children and adults.
FDA Approves First Recombinant Coagulation Factor IX
The US Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older.
FDA Approves Lenalidomide
On June 5, 2013, the US Food and Drug Administration approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
FDA Clears First Blood Tracking Device That Uses Radio Frequency Identification Technology
iTrace for Blood Centers, the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the US Food and Drug Administration.
FDA Approves First Nimodipine Oral Solution, Nymalize
On May 10, the US Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage).
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.
FDA Approves Kcentra
The US Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.