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 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. 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. The identifier primarily refers to the FDA Biologics
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
: 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