FDA Alerts
New FDA Boxed Warning for Codeine
The US Food and Drug Administration (FDA) is updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. Codeine is converted to morphine by the liver. These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the ...
FDA Approves First Retinal Implant for Adults with Rare Genetic Eye Disease
The US Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP).
FDA Approves Pomalyst for Advanced Multiple Myeloma
The US Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
FDA Offers New Guidance on Developing Drugs for Alzheimer’s Disease
Today, the US Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia.
FDA Approval of Generic Doxil is Expected to Help Resolve Shortage
The U.S. Food and Drug Administration today approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
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.
FDA Approves Three New Drug Treatments for Type 2 Diabetes
The US Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.
FDA Approves Gleevec for Children With Acute Lymphoblastic Leukemia
The US Food and Drug Administration today approved a new use of Gleevec ( imatinib ) to treat children newly diagnosed with Philadelphia chromosome positive ( Ph +) acute lymphoblastic leukemia (ALL).
FDA Approves Exjade for Genetic Blood Disorder
The US Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
Tolvaptan has Liver Injury Risk Says FDA
Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca.