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:

: 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

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

: The drug was not referred to an advisory committee because its safety profile was similar to other approved drugs in its class and didn't raise unexpected issues.

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