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

While the pharmaceutical review is the most prominent, the number may also refer to: CDTL Review and Division Summary Memo for Regulatory Action 125469

Detailed FDA reviews for BLA 125469 concluded that the clinical data provided "sufficient data to support approval". Key findings from the regulatory process included: The identifier primarily refers to the FDA Biologics

: 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