H&P Industries, Triad Group, and company officers agree to correct deficiencies
Category Archives: Drug Safety Information Podcasts
FDA approves Potiga to treat seizures in adults
On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.
Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.
FDA clears new system to perform simultaneous PET, MRI scans
The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging (MRI) scan.
FDA approves redesigned labels for some Merck drugs
The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.
FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology
The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.
FDA announces new safety recommendations for high-dose simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose–80 milligram (mg)–has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
FDA: Pfizer will voluntarily suspend sale of animal drug 3-Nitro
The U.S. Food and Drug Administration today announced that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend U.S. sales of the animal drug 3-Nitro (roxarsone), a product used by poultry producers since the 1940s.
FDA: DDS probiotic products seized
U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.
FDA statement on E. coli O104 outbreak in Europe
The U.S. FDA has been in routine contact with the European Union and the U.S. Centers for Disease Control and Prevention to monitor the current outbreak of E. coli O104 and to track any illnesses in the U.S. that may be related to the outbreak
FDA seizes elderberry juice concentrate at Kansas company
At the request of the U.S. Food and Drug Administration, U.S Marshals seized elderberry juice products that have been distributed by Wyldewood Cellars Inc., based in Peck, Kansas., because the products are unapproved and misbranded drugs.