The U.S. Food and Drug Administration today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.
Category Archives: Drug Safety Information Podcasts
FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy
The U.S. Food and Drug Administration today approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the presence of a gene mutation.
FDA prompts companies to remove certain unapproved oxycodone products from market
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market.
FDA approves first DNA test to help manage CMV infection in organ transplant patients
The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
FDA approves first over-the-counter home use HIV test kit
The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
FDA proposes unique device identification system for medical devices
FDA proposes that most medical devices distributed in the United States carry a unique device identifier or UDI.
FDA approves Myrbetriq for overactive bladder
The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
FDA approves Belviq to treat some overweight or obese adults
The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.
FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections
The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.
FDA approves first glaucoma stent for use with cataract surgery
Today, the iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L, was approved by the U.S. Food and Drug Administration. This is the first device approved for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication to reduce intraocular pressure.