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

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

: While initially approved for adults, supplemental reviews (like sBLA 125469/S-051) have assessed its use in pediatric patients aged 10–17 years. : Recent 2024 reviews led to labeling updates

: 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 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.