The FDA threw another hurdle in the path of drugmakers selling "Low T" drugs, requiring manufacturers to update labels to warn that the meds could increase the risk of heart attacks and strokes and should not be prescribed to treat age-related symptoms.
The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."
Three Japanese companies known more for their cameras than medical devices have been called on the U.S. FDA carpet to explain why their medical scopes may be associated with at least two "superbug" deaths.
A Ranbaxy Laboratories effort to have two of its drugs returned to the U.S. FDA's marketing-approval list was quashed when a U.S. district judge dismissed the suit at the request of the agency.
The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.
The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.
The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.
Currently, there are several generics on the U.S. market of oral antifungal agent ketoconazole. But consumer advocacy organization Public Citizen is trying to change that.
Sagent Pharmaceuticals has transferred production of atracurium besylate injection to its own plant after the FDA spotted GMP problems at the CMO that was manufacturing the drug. The FDA observations relate to aseptic practices at Emcure Pharmaceuticals, an Indian manufacturer behind earlier recalls by Pfizer and Teva.
Sun Pharma issued a recall of 3,363 bottles of its levetiracetam extended-release drug for treating epilepsy in the United States after the tablets failed dissolution tests.