Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.
Category Archives: Food Safety News
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of that effort is promoting more widespread, safe adoption of MAT as a way to help more people overcome addiction.
FDA clears first duodenoscope with disposable distal cap
The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
FDA approves new treatment for adults with relapsed follicular lymphoma
The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.
FDA approves first biosimilar for the treatment of cancer
The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Natural Grocers Issues Recall on Organic Deglet Dates Due to Mislabeling and Undeclared Allergens
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut run the risk of a serious or life-threatening allergic reaction if they consume this product.
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FDA permits marketing of mobile medical application for substance use disorder
Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.
Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain.
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Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy