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2: data are given as geometric mean (coefficient of variability CV%)
One of the relevant exclusivity periods applies to New Drug Applications (NDA) for approved products containing new chemical entities (NCEs), whereby an ANDA with a paragraph IV certification may not be submitted until four years after the NDA was approved (i.e., the NCE-1 date)
However, those with more advanced liver diseaseparticularly cirrhosis or decompensated liver diseaseshould generally avoid NSAIDs altogether
Although the risk appears to be extremely low, it serves as a reminder that all medications carry both benefits and risks
PubChem / NCBI (2024) 11
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