the food and drug administration (fda) has approved a supplement to the new drug application (nda) 202155/s-002 for eliquis (apixaban) 2.5 and 5 mg tablets. the supplement addresses the differentiation between temporary interruption and discontinuation of apixaban, new information and dosing recommendations for patients with end-stage renal disease (esrd), and data from a drug-drug interaction study with prasugrel. the changes to the full prescribing information (fpi) include: the title of subsection 2.3 was changed to "temporary interruption for surgery and other interventions"; the dosing adjustment for moderate renal impairment was updated to include a recommended dose of 5 mg twice daily for esrd patients on hemodialysis, with a reduced dose of 2.5 mg twice daily for patients aged 80 years or older or with a body weight of 60 kg or less; a new subsection 8.6 was added for esrd patients maintained on hemodialysis; and a new figure in subsection 12.3 was included to show the effect of specific populations on apixaban's pharmacokinetics. minor editorial and formatting changes were also made. the fpi highlights and table of contents were updated to reflect these changes. the fda has approved the supplement, effective from the date of the letter, for use as recommended in the enclosed labeling text. the content of the labeling must be submitted in structured product labeling (spl) format within 14 days, and all pending supplemental applications with labeling changes must be amended accordingly. the application is exempt from the pediatric research equity act (prea) requirements because none of the criteria apply. the fda reminds the applicant to comply with reporting requirements for an approved nda. the approval was issued by mary r. southworth, pharm.d., deputy director for safety, division of cardiovascular and renal products, office of drug evaluation i, center for drug evaluation and research.the food and drug administration (fda) has approved a supplement to the new drug application (nda) 202155/s-002 for eliquis (apixaban) 2.5 and 5 mg tablets. the supplement addresses the differentiation between temporary interruption and discontinuation of apixaban, new information and dosing recommendations for patients with end-stage renal disease (esrd), and data from a drug-drug interaction study with prasugrel. the changes to the full prescribing information (fpi) include: the title of subsection 2.3 was changed to "temporary interruption for surgery and other interventions"; the dosing adjustment for moderate renal impairment was updated to include a recommended dose of 5 mg twice daily for esrd patients on hemodialysis, with a reduced dose of 2.5 mg twice daily for patients aged 80 years or older or with a body weight of 60 kg or less; a new subsection 8.6 was added for esrd patients maintained on hemodialysis; and a new figure in subsection 12.3 was included to show the effect of specific populations on apixaban's pharmacokinetics. minor editorial and formatting changes were also made. the fpi highlights and table of contents were updated to reflect these changes. the fda has approved the supplement, effective from the date of the letter, for use as recommended in the enclosed labeling text. the content of the labeling must be submitted in structured product labeling (spl) format within 14 days, and all pending supplemental applications with labeling changes must be amended accordingly. the application is exempt from the pediatric research equity act (prea) requirements because none of the criteria apply. the fda reminds the applicant to comply with reporting requirements for an approved nda. the approval was issued by mary r. southworth, pharm.d., deputy director for safety, division of cardiovascular and renal products, office of drug evaluation i, center for drug evaluation and research.