Stratagraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat

Approval

ApplicationBLA 125730

Approval dateJun 15, 2021

Approval year2021

SponsorStratatech Corporation

FDA-approved use

To promote durable wound closure & regenerative healing in the treatment of adult patients with debrided thermal burns that contain intact dermal elements, and for which surgical intervention is clinically indicated

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA-approved label (PDF)

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Stratagraft:

"What was the basis for Stratagraft's approval — what trials, what endpoints?"
"What adverse events did the FDA flag in the Stratagraft medical review?"
"What regulatory pathway did Stratagraft use — priority review, breakthrough, accelerated approval?"