The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
Category Archives: Food Safety News
FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes
The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
FDA takes action against Vermont dairy farm for illegally administering drugs to cattle
Today, the U.S. Department of Justice entered a consent decree of permanent injunction in the District of Vermont against the Correia Family Limited Partnership, doing business as Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its partners, Anthony Correia, Barbara Correia and Stephen Correia. The decree accompanies a complaint filed at the request of the U.S. Food and Drug Administration.
FDA approves new oral therapy to treat ALK-positive lung cancer
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
FDA approves first emergency treatment for overdose of certain types of chemotherapy
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
The Sweet Leaf Tea Company Issues Voluntary Nationwide Recall of Tea in Glass Bottles
The Sweet Leaf Tea Company announced today that it is voluntarily recalling Sweet Leaf Tea in 16 ounce glass bottles out of an abundance of caution because of the possible presence of glass fragments. This was the result of glass breakage during the filling process.
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FDA allows marketing of cooling cap to reduce hair loss during chemotherapy
Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
FDA approves first recombinant von Willebrand factor to treat bleeding episodes
The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD.