FDA Alerts
FDA Approves Nexavar to Treat Type of Thyroid Cancer
The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine).
FDA Approves First Generic Versions of Aciphex Delayed-Release Tablets to Treat GERD
The US Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
FDA Approves Clinolipid For Intravenous Nutrition
Today, the US Food and Drug Administration approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink.
FDA Approves New Drug to Treat Major Depressive Disorder
The US Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
The US Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting).
FDA Approval Expands Access to Artificial Heart Valve for Inoperable Patients
The US Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
FDA Requiring Color Changes to Duragesic Pain Patches to Aid Safety
The US Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily.
FDA Prohibits Manufacture of FDA-Regulated Drugs from Ranbaxy's Mohali, India, Plant and Issues Import Alert
The US Food and Drug Administration today issued an import alert under which US officials may detain at the US border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India.
FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The US Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.