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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2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
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 ...
Phentermine is a stimulant that suppresses appetite by affecting the central nervous system. ... Some drugs used for weight loss are only FDA-approved for improved blood sugar control in adults ...
(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 ...
(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious.
CGS-21680 is a specific adenosine A 2A subtype receptor agonist.It is usually presented as an organic hydrochloride salt with a molecular weight of 536.0 g/M.It is soluble up to 3.4 mg/mL in DMSO and 20 mg/mL in 45% (w/v) aq 2-hydroxypropyl-β-cyclodextrin.
The medication is produced by the pet drug firm Zoetis and was approved by the FDA last year. The dog medication Librela is likely sickening and killing dogs, the FDA warned. Ermolaev Alexandr ...