The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.
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Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).
First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray
First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder
FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety
FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.
FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk
FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein
Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product,
manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain
undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the
risk of serious or life-threatening allergic reaction if they consume these products.
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Roche Diagnostics to Replace CoaguChek® XS PT Test Strips
Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.
The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk
The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.