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:

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

: While initially approved for adults, supplemental reviews (like sBLA 125469/S-051) have assessed its use in pediatric patients aged 10–17 years. Detailed FDA reviews for BLA 125469 concluded that

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 125469