The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Category Archives: Drug Safety Information Podcasts
FDA allows marketing of new stent for treating pseudocysts of the pancreas
The U.S. Food and Drug Administration today allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts (fluid and tissue filled cavities) that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
FDA allows marketing of first device to relieve migraine headache pain
The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
FDA approves first generic versions of antidepressant drug Cymbalta
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
FDA takes significant steps to address antimicrobial resistance
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
FDA approves Sovaldi for chronic hepatitis C
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Solvadi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
FDA approves first drug treatment for Peyronie’s disease
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
FDA reaches $1.25 million settlement with Advanced Sterilization Products and company executives
The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.