The U.S. Food and Drug Administration today allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial and parasitic causes of infectious gastroenteritis from a single patient sample.
Category Archives: Food Safety News
Island Delights Volutarily Recalls Island Delights Coconut Haystack Candy Due to Undeclared Milk
Island Delights, Inc. today recalled 492 Bags of its Coconut Haystack Candy due to mislabeling and undeclared allergens. This was discovered during an audit from the Ohio Department of Agriculture on January 7, 2013.
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FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Giant & Martin’s Alerts Customers To Voluntary Recall Of Ocean Beauty Seafood Smoked Salmon
GIANT Food Stores, LLC and MARTIN’S Food Markets, following a recall by Ocean Beauty Seafoods LLC, announced it removed from sale several varieties of smoked salmon due to possible contamination by listeria monocytogenes.
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FDA issues draft guidance on abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.
FDA proposes new food safety standards for foodborne illness prevention and produce safety
The U.S. Food and Drug Administration today proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules.
FDA approves first anti-diarrheal drug for HIV/AIDS patients
The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.
FDA approves first drug to treat multi-drug resistant tuberculosis
On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA approves new orphan drug for rare cholesterol disorder
On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.