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FDA

Latest Headlines

Latest Headlines

FDA calls for heart, stroke warnings on 'Low T' meds

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.

FDA requires new labeling on insulin pens to ward off spread of infections

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 device firms slapped with U.S. FDA queries on possible 'superbug' link

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.

Ranbaxy bid to regain marketing approval for key generics shot down by federal judge

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.

FDA warns manufacturer of failing to report corrections to its device disinfection system

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.

New Jersey compounder indicted over unsanitary manufacturing

The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.

FDA in midst of updating endoscope labels implicated in 'superbug' infections

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.

Consumer group petitions FDA to pull generic antifungal med

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 brings production in-house after FDA finds fault with Indian CMO

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.

India's Sun Pharma recalls epilepsy treatment levetiracetam batch over failed dissolution tests

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.