The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
Category Archives: Food & Drug Recalls
Tristar Equine Issues Voluntary Recall of Gastrotec
Tristar Equine Marketing, LLC is voluntarily recalling all lots of Gastrotec down to the consumer level. Gastrotec was previously marketed by Tristar as an OTC drug for use in horses, and contains a combination of Omeprazole and Misoprostol.
FDA approves first pathogen reduction system to treat plasma
The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).
FDA announces Pharmacy Compounding Advisory Committee members
The U.S. Food and Drug Administration today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members – 12 voting and two non-voting – who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter
Baxter International Inc. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.