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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.
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2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The US Food and Drug Administration on Tuesday did not approve a needle-free epinephrine for treatment of severe allergic reactions, a move that drugmaker ARS Pharmaceuticals called surprising.
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...
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 ...
A common stomach bug is surging, according to new data from the US Centers for Disease Control and Prevention. In the week of December 5, there were 91 outbreaks of norovirus reported, up from 69 ...
Probenicid lowers the concentration of certain drugs in urine drug screens by reducing renal excretion of these drugs. Historically, probenecid has been used to increase the duration of action of drugs such as penicillin and other beta-lactam antibiotics. Penicillins are excreted in the urine at proximal and distal convoluted tubules through ...