What approval letter is associated with Livtencity (maribavir) NDA 215596?
You’re looking for the U.S. FDA approval letter tied to the New Drug Application (NDA) 215596 for Livtencity (maribavir). The “regulatory project manager” typically refers to the FDA internal contact listed on that approval letter.
However, the provided information doesn’t include the actual approval letter text, filing metadata, or the FDA contact name. To answer accurately (with the regulatory project manager name and any letter details like approval date/signature), I’d need the approval letter itself or at least the document’s key fields (FDA division/center, approval date, and the “Regulatory Project Manager” line).
Where can you find the NDA approval letter and the “Regulatory Project Manager” line?
The NDA approval letter is normally posted in public FDA approval-letter repositories (commonly the FDA “Drugs@FDA” system for small-molecule drugs), and the letter typically includes an FDA staff contact line for the Regulatory Project Manager.
If you paste the approval letter text (or upload the letter), I can extract:
- the Regulatory Project Manager name,
- the approval date,
- the application type and review division (as shown),
- and any key conditions or labeling/REMS statements included in the letter.
Who is the regulatory project manager listed for NDA 215596 in the approval letter?
The regulatory project manager name is not available in the information provided in your prompt. If you share the relevant excerpt from the approval letter (the section that lists “Regulatory Project Manager”), I can report the exact name and format it cleanly for your regulatory record.
How to search for Livtencity NDA 215596 approval letter quickly
If you’re doing this yourself, the most direct approach is to search for:
- “Drugs@FDA Livtencity NDA 215596 approval letter”
- or search within FDA’s approval letter pages for NDA 215596
Once you open the letter, look for a line near the top or signature block that reads “Regulatory Project Manager.”
What if you can’t find the project manager name on the public page?
Sometimes public copies include the letter but not all internal routing/contact fields, or the project manager may appear only in the signed letter PDF version. If the webpage version doesn’t show it, downloading the PDF letter usually resolves this.
If you paste what you can see (even partial), I can tell you where the regulatory project manager appears and what it should say.
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Sources
No sources were provided in the prompt, and I don’t have the approval letter content or a citation-enabled document to extract the Regulatory Project Manager name.