The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information
The FDA says it will release in July a controversial and major final rule that would allow generic drug companies to up date their labels with new safety information
like their reference product counterparts have done for almost 30 years.
., and the status of the pending CBE-o supplement." (55) The proposed amendment addresses safety concerns about unilateral label changes for generic drugs by permitting the FDA to send a request letter notifying the brand-name manufacturer of the new safety information
. (56) The FDA would then evaluate the proposed label change for the generic drug and approve it for both the generic drug's label and the corresponding brand-name drug's label.
A NEW safety information
resource is being made available for the first time to scooter riders in the UK.
A proposed Food and Drug Administration rule would speed the dissemination of new safety information
about generic drugs to providers and patients by allowing generic drug makers to use the same process as brand-name drug manufacturers to update safety information in the product labeling.
The second edition includes new safety information
and new chapters on resistive-capacitive circuits, and resistive-inductive-capacitive circuits.
The new safety information
was based on an FDA review of several epidemiologic studies reporting an increased risk of fractures of the hip, wrist, and spine with PPI use.
The resubmission also included a final safety update that provided updated or new safety information
on patients in clinical studies who have been treated with Horizant.
In May, the Food and Drug Administration (FDA) notified healthcare professionals and patients of revisions to the prescription and over-the-counter (OTC) labels for proton pump inhibitors (which work by reducing the amount of acid in the stomach and are used to treat acid reflux) to include new safety information
about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
Patient safety is central to our public health mission, and FDA is committed to delivering new safety information
to nurses and other clinicians at the point-of-care in order to reduce the risk of drug or device-related harm, improving patient health outcomes.
The FDA announced it has acted on new safety information
about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide) Injection, a drug used to treat type 2 diabetes.