The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Category Archives: Drug Recalls & Safety Notices
FDA approves injectable gel to treat fecal incontinence
The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
FDA to make enforcement and compliance activities accessible online
The U.S. Food and Drug Administration today announced that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online.
FDA seeks comment on preventive controls against foodborne illness
The Food and Drug Administration is seeking public comment on preventive control measures for food facilities through a public docket opened this week as part of the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January.
FDA takes action against illegal marketing of tobacco products
The U.S. Food and Drug Administration today announced it issued 11 warning letters last week to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease.
FDA approves Incivek for hepatitis C
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.
FDA: Do not feed SimplyThick to premature infants
The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.
FDA approves Sutent for rare type of pancreatic cancer
The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
FDA clears first test to diagnose Q fever in military serving overseas
The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The test was developed by Idaho Technology Inc.
FDA approves new HIV treatment
The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).