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The FDA required Takeda to conduct this safety study when the medicine was approved in 2009. The febuxostat drug labels already carry a warning and precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
It received FDA approval on 22 December 2015. [3] The European Commission granted a marketing authorisation valid throughout the European Union on 18 February 2016. [ 4 ] In February 2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
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The U.S. Food and Drug Administration's chief had a "robust discussion" with the White House this week about the timeline for coronavirus vaccine approvals and believes vaccinating 20 million ...
(Reuters) -The U.S. Food and Drug Administration granted accelerated approval to French drugmakers Ipsen and Genfit's drug for a chronic inflammatory liver disease, Iqirvo, the companies said on ...
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate. [1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority ...
Febuxostat is only recommended in those who cannot tolerate allopurinol. [71] There are concerns about more deaths with febuxostat compared to allopurinol. [72] Febuxostat may also increase the rate of gout flares during early treatment. [73] However, there is tentative evidence that febuxostat may bring down urate levels more than allopurinol ...