label and packaging changes

FDA Issues New Label Change for Codeine and Tramadol
FDA Issues New Label Change for Codeine and TramadolDecades of research has led to a flurry of new warnings.
FDA’s updated fluoroquinolone warnings: What urologists should know. Prescribers should know that the FDA has updated its warnings to say that fluoroquinolones should not be prescribed to patients who have other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections
New guidance on generic opioids, biosimilars labeling coming from FDAFDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.
HARBOR results lead to ranibizumab label change
HARBOR results lead to ranibizumab label changeFindings from the HARBOR study on ranibizumab for wet macular degeneration prompted new labeling for a potentially less frequent than monthly dosing, depending on individual responses to treatments.
Label, packaging changes requested for some OTC topical antiseptic productsFDA has requested label and packaging changes for certain over-the-counter topical antiseptic products to decrease the risk of infections from these products, which in rare cases have resulted in deaths.