The letter from Bristol-Myers Squibb to Dr. Linda Gambone, Associate Director of Global Regulatory Sciences, addresses the supplemental New Drug Application (sNDA) for Eliquis (apixaban) 2.5 and 5 mg Tablets, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA). The sNDA includes changes to the Full Prescribing Information (FPI) to differentiate between temporary interruption and discontinuation, provide dosing recommendations for patients with end-stage renal disease (ESRD), and include data from a drug-drug interaction study with prasugrel. Key changes include: - Renaming subsection 2.3 to "Temporary Interruption for Surgery and Other Interventions." - Modifying subsection 2.7 Renal Impairment to specify dosing for ESRD patients on hemodialysis. - Adding a new subsection 8.6 for ESRD patients maintained with hemodialysis. - Replacing Figure 3 in subsection 12.3 with updated pharmacokinetic data for ESRD subjects on hemodialysis. - Making minor editorial and formatting changes throughout the FPI. The FDA has approved the supplemental application and requires the submission of the updated labeling in structured product labeling (SPL) format within 14 days. The company is also reminded of reporting requirements for an approved NDA. The letter concludes with contact information for further inquiries.The letter from Bristol-Myers Squibb to Dr. Linda Gambone, Associate Director of Global Regulatory Sciences, addresses the supplemental New Drug Application (sNDA) for Eliquis (apixaban) 2.5 and 5 mg Tablets, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA). The sNDA includes changes to the Full Prescribing Information (FPI) to differentiate between temporary interruption and discontinuation, provide dosing recommendations for patients with end-stage renal disease (ESRD), and include data from a drug-drug interaction study with prasugrel. Key changes include: - Renaming subsection 2.3 to "Temporary Interruption for Surgery and Other Interventions." - Modifying subsection 2.7 Renal Impairment to specify dosing for ESRD patients on hemodialysis. - Adding a new subsection 8.6 for ESRD patients maintained with hemodialysis. - Replacing Figure 3 in subsection 12.3 with updated pharmacokinetic data for ESRD subjects on hemodialysis. - Making minor editorial and formatting changes throughout the FPI. The FDA has approved the supplemental application and requires the submission of the updated labeling in structured product labeling (SPL) format within 14 days. The company is also reminded of reporting requirements for an approved NDA. The letter concludes with contact information for further inquiries.