FDA Alerts
Multiple Myeloma Rx Approved
On July 24, 2015, the U. S. Food and Drug Administration approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.
New Skin Cancer Rx Gets Green Light
On July 24, 2015, the U. S. Food and Drug Administration approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
FDA Approves New Leg Prosthesis for Amputees
The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
FDA Approves Targeted Rx for Lung Cancer
The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
New Schizophrenia Rx Approved
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).
New Antiplatelet Rx Approved
The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart.
Soft Tissue Fillers in Face May Pose Risks
The US Food and Drug Administration (FDA) today issued a warning regarding the unintentional injection of soft tissue filler into blood vessels in the face.
FDA Approves Rx for Rare Lung Disease
The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.
Two New IBS Treatments Approved
The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
FDA: Diabetes Rx May Pose Serious Health Risk
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.