The U.S. 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.
Category Archives: Drug Safety Information Podcasts
New medical device treats urinary symptoms related to enlarged prostate
The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
Federal judge grants FDA request for consent decree with Idaho farm
The U.S. District Court for the District of Idaho entered a consent decree of permanent injunction against owner Gregory T. Troost, doing business as T&T Cattle and T&T Cattle Pearl, and manager Mark A. Mourton of Parma, Idaho for violations including illegally administering animal drugs for uses that are not approved by the U.S. Food and Drug Administration.
FDA approves Abraxane for late-stage pancreatic cancer
The U.S. Food and Drug Administration today expanded the approved use of Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with late-stage (metastatic) pancreatic cancer.
Federal judge approves consent decree against Dakota Laboratories
Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws. The U.S. Food and Drug Administration entered into a consent decree of permanent injunction on Aug. 26, 2013 which enjoined the drug maker and distributor for repeated failure to comply with federal drug manufacturing requirements, known as Current Good Manufacturing Practices (cGMPs).
New test system identifies 193 different yeasts and bacteria known to cause illness
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.
FDA reminds health care providers not to use sterile products from NuVision Pharmacy
The U.S. Food and Drug Administration is reminding health care providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. Health care providers should not administer any NuVision Pharmacy sterile products to patients because the products’ sterility is not assured.
La FDA aprueba nuevo medicamento para el tratamiento de la infección de VIH
La Administración de Alimentos y Medicamentos aprobó hoy Tivicay (dolutegravir), un nuevo fármaco para tratar la infección de VIH-1.