Maine company holds cold smoked salmon product after FDA order
A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.
FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.
FDA to protect important class of antimicrobial drugs for treating human illness
The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.
FDA expands use of Prevnar 13 vaccine for people ages 50 and older
Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.
FDA to approve shared system REMS for TIRF products
The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.
FDA: Chicago-area sandwich manufacturer agrees to stop production
The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.
FDA: Do not use ShoulderFlex Massager
The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.
FDA expands use of HIV drug Isentress to children and adolescents
Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.