Detailed FDA reviews for BLA 125469 concluded that the clinical data provided "sufficient data to support approval". Key findings from the regulatory process included:
: Recent 2024 reviews led to labeling updates regarding risks for patients undergoing surgeries requiring general anesthesia, as well as the addition of "dysgeusia" (taste distortion) as a potential side effect. Other Potential Matches 125469
The identifier primarily refers to the FDA Biologics License Application (BLA) for Trulicity (dulaglutide) , an injectable medication used for type 2 diabetes. Clinical & Regulatory Review Detailed FDA reviews for BLA 125469 concluded that