The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
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Bravo Recalls Select Chicken Pet Foods Because of Possible Salmonella Health Risk
Bravo Pet Foods of Manchester, CT is recalling select lots of Bravo Chicken pet foods for dogs and cats due to concerns of the possible presence of Salmonella.
The recall was initiated after routine testing by the New York State Department of Agriculture revealed the presence of Salmonella spp. Poly A contamination.
FDA approves new treatment for most common form of advanced skin cancer
The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
FDA approves Technivie for treatment of chronic hepatitis C genotype 4
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars
The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats.
Life & More, L.L.C. Issues Nationwide Voluntary Recall of Akttive High Performance Fat Burner Gold Capsules Due to Undeclared Drug Ingredients
Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.
Life & More, L.L.C. Issues Nationwide Voluntary Recall of Akttive High Performance Fat Burner Gold Capsules Due to Undeclared Drug Ingredients
Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.
FDA approves diagnostic test to differentiate between types of HIV infection
The U.S. Food and Drug Administration today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
FDA Food Safety Challenge winners develop innovative technologies to detect Salmonella
The U.S. Food and Drug Administration today announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively.
Osamu Corporation Voluntarily Recalls Frozen Yellow Fin Tuna Chunk Meat Due to Possible Health Risk
Osamu Corporation of Gardena, CA is recalling Frozen Yellow Fin Tuna Chunk Meat (Lot #68568) sold to AFC Corporation of Rancho Dominquez, CA sourced from one processing plant in Indonesia because the Minnesota Department of Health Investigators found samples of this product from one retail location in Minnesota to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.