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The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney disease and major cardiac events by 24%, the company said.
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with ...
In December 2016, a New Drug Application was filed with the US Food and Drug Administration (FDA), and in October 2017, a FDA advisory committee approved it unanimously. [65] In December 2017, the injectable version with the brand name Ozempic was approved for use by people with diabetes in the United States, [30] [66] and, in January 2018, in ...
Ozempic was approved by the FDA in 2017 for use in adults with Type 2 ... Use of semaglutide has increased so much that the FDA added it to a list of drugs that were in shortage in March 2022, ...
The study noted an A1c difference at weel 30 of -1.2 in those that took 0.5 mg of Ozempic, and -1.4 I those that took 1.0 mg weekly, when compared to the placebo group.
Ozempic, which shares the same active ingredient as Wegovy, but is indicated to treat type 2 diabetes, received FDA approval for a cardiovascular disease indication four years earlier, in 2020.
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