FDA Alerts
FDA Approves Pathogen Reduction System to Treat Platelets
The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets.
FDA Approves Xtoro to Treat Swimmer’s Ear
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.
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 Approves New Rx for Advanced GEP NETs
On December 16, 2014, the U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
First Screening Test for Group of Newborn Genetic Disorders Gets FDA Thumbs Up
The U.S. Food and Drug Administration today 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 Heart Disease Risk
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 Warns of Risk in Children's Use of Dietary Supplement
FDA is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons.
Company Stops Operations Due to Repeated Food Safety Violations
William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements.
FDA Warns of Rare but Serious Skin Reactions from Ziprasidone
FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body.
FDA Approves First Test for Group of Human Retroviruses
The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II).