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Novo Nordisk, the pharmaceutical institution down Ozempic, has received a informing missive from the U.S. Food and Drug Administration implicit issues with its procedures for reporting imaginable broadside effects of the flagship diabetes drug, which is besides prescribed for value loss.
In the letter, dated March 5, the FDA cited 3 deaths among patients receiving semaglutide, the generic sanction for the medicine successful Novo Nordisk's Ozempic and Wegovy, which were allegedly not reported decently to the agency. Those deaths included 1 suicide, according to the FDA. Another lawsuit progressive a diligent that reported suicidal ideations portion taking semaglutide.
The FDA did not speculate arsenic to whether the deaths oregon different broadside effects were needfully linked to the medication. Its missive focused connected the information that Novo Nordisk seemingly violated its protocols for reporting adverse symptoms that could perchance beryllium tied to the drug.
FDA investigators discovered problems with Novo Nordisk's reporting compliance erstwhile it conducted an inspection astatine the Danish drugmaker's U.S. office successful Plainsboro, New Jersey, successful aboriginal 2025. It was conducted arsenic portion of the agency's Bioresearch Monitoring Program, which aims to guarantee that close and timely accusation astir merchandise information is submitted to the FDA for monitoring.
Novo Nordisk responded to the FDA's informing missive connected Tuesday, saying successful a connection that it had been "working diligently" to code the agency's concerns since its inspection took spot past year. The institution said the missive mostly sought much details astir the steps the institution has taken since the inspection to comply with post-marketing adverse cause experience, oregon PADE, regulations. But the missive did not "make immoderate conclusions astir the prime oregon information of our medicines," the institution said.
"Novo Nordisk takes PADE reporting requirements earnestly and we program to code the requests successful the Warning Letter expeditiously and holistically," said Anna Windle, the caput of objective development, aesculapian and regulatory affairs astatine Novo Nordisk U.S. "We are assured that we volition resoluteness the matters outlined successful Warning Letter to the FDA's afloat satisfaction."
Another caller valuation by the FDA determined that there was nary connection betwixt termination and GLP-1 drugs specified arsenic Ozempic oregon Wegovy. The bureau successful January requested the removal of boxed warnings for suicidal behaviour oregon ideation from those medications.
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