FDA Alerts
FDA Approves Rx for Diabetic Retinopathy
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
FDA Approves New Use of Glucose Monitoring System for Hospitals
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized.
FDA Allows Marketing of Diabetes Test
Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes.
FDA Approves Afrezza to Treat Diabetes
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.
FDA Advises Against Use of GenStrip Blood Sugar Test Strips
GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips—this means that the test strips are not made by the same company as the meter with which they are used.
FDA Approves New Diabetes Rx
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
FDA Approves Farxiga for Type 2 Diabetes
The U.S. Food and Drug Administration today approved Farxiga (dapagliflozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
FDA Removes Restrictions on Avandia
The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine.
Voluntary Recall of Specified Lots of Nova Max Glucose Test Strips
Nova Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.
FDA Alerts Companies to Stop Illegal Sale of Treatments for Diabetes
The US Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.