FDA approves Tanzeum to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Archive for the ‘Food Safety News’ category
FDA approves expanded indication for certain pacemakers and defibrillators
The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.
FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules
The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.
FDA approves new hand-held auto-injector to reverse opioid overdose
The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a […]
FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse
For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. […]
Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication
The U.S. Department of Health and Human Services (HHS) today released a draft report that includes a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT) that promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally-mandated report proposes to clarify federal regulatory oversight of […]
FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds
Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing […]
Koru Pacific Packaging Announces a Voluntary Recall for One Lot # AH!LASKA® Organic Cocoa Non-Dairy Chocolate Mix, 12 oz. Canister Due to Possible Milk Allergen
KORU Pacific Packaging, today issued a voluntary recall of AH!LASKA®, because one lot (LOTI# 3280 BEST BY APR/2015) of the product may contain milk, which is not labeled in the ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume […]
FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies
The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first […]
FDA orders Wash.-based smoked seafood manufacturer to cease operations
The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.
FDA approves Topamax for migraine prevention in adolescents
Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.
FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B
The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
FDA approves Otezla to treat psoriatic arthritis
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
FDA approves first implantable hearing device for adults with a certain kind of hearing loss
The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this […]
FDA approves Impavido to treat tropical disease leishmaniasis
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Some lots of Simply Lite brand dark chocolate recalled
The U.S. Food and Drug Administration warns consumers that it has tested and found milk protein in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is a major food allergen, but it is […]
Infinite Herbs, LLC Voluntarily Recalls One Lot of Basil Organic Clamshells Because of Possible Health Risk
Infinite Herbs LLC of Miami, Florida is voluntarily recalling one lot of its 2.5 ounce packages of Organic Basil because of potential contamination with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Read The Complete Story!
FDA allows marketing of first medical device to prevent migraine headaches
Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
Crown Food Distributors, Inc. Issues Allergy Alert on Undeclared Sulfites and Undeclared Yellow #6 in Golden Natural Fruit Island
Crown Food Distributors, Inc. of North Bergen, NJ is recalling 25 oz. large round plastic containers of “Golden Natural Fruit Island” because they contain undeclared sulfites and undeclared FD & C yellow #6. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume […]