The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.
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FDA approves first U.S. treatment for Chagas disease
The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.
Dedinas-Franzak Enterprises Issues Allergy Alert On Undeclared Milk In Big Win Butter Popcorn
Dedinas-Franzak Enterprises is recalling Big Win, Butter Popcorn Artificially Flavored 5 OZ, UPC #0-11822-58492-0, This product is artificially flavored and milk is not specifically called out in the Allergen Statement. The product may contain milk and people who have an allergy or severe sensitivity to Milk may run the risk of serious or life-threatening allergic reaction if they consume this product. The concern was identified through a non-illness consumer complaint in relation to flavor.
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.
FDA warns US Stem Cell Clinic of significant deviations
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific
Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice
requirements, including some that could impact the sterility of their products, putting patients at risk.
FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients
The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to
StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly
Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a
vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100
doses of the vaccine, and although one vial was partially used, four of the vials were intact.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty
As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels.
Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market
Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.
Recall of Certain Frozen Organic Dark Sweet Pitted Cherry Products Due to Possible Contamination by Listeria Monocytogenes
Out of an abundance of caution, SunOpta Inc’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of certain frozen organic dark sweet pitted cherry products due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Centurion Labs Issues Voluntary Nationwide Recall of Ninjacof (Lot # 200N1601) and Ninjacof A (Lot# 201NA1601) Products Due to Potential Burkholderia Cepacia Contamination
Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.