What is the “approval letter” for Livtencity (maribavir) dated November 23, 2021?
On November 23, 2021, the FDA approved maribavir (Livtencity). The “approval letter” is the FDA’s official written notice to the sponsor (the company that submitted the application) that the drug application was approved. This letter typically includes the product’s approved indication(s), any required labeling language, and postmarketing or other regulatory commitments.
However, the specific “regulatory project manager” name listed on that November 23, 2021 FDA approval letter is not provided in the information you supplied.
Who was the regulatory project manager (RPM) listed on that FDA approval letter?
FDA approval letters usually identify an FDA staff contact, often a “Regulatory Project Manager,” but I can’t extract the actual RPM name from your prompt alone.
If you paste the text of the approval letter (or share the FDA document link/letter header), I can point out the exact line where the RPM is listed and report it verbatim.
Where can I find the FDA approval letter from Nov. 23, 2021?
People typically locate these letters via:
- the FDA drug approval package for maribavir (Livtencity),
- the FDA “Drugs@FDA” record,
- or the PDF “Approval Letter” linked in the approval package.
If you provide the URL you’re using, I can help you confirm it’s the correct Nov. 23, 2021 letter and identify the RPM field within it.
Why does the RPM name matter?
The RPM name is mainly useful for:
- identifying the FDA point of contact for regulatory questions about the approved application,
- routing postapproval submissions (e.g., labeling updates, postmarketing requirements/commitments),
- and administrative clarification during ongoing oversight.
It’s not the same as the FDA reviewer/medical reviewer and usually doesn’t affect the approval outcome.
Quick next step
Send either:
1) the approval-letter PDF text (or screenshot), or
2) the exact FDA page/link you’re looking at,
and I’ll extract the “Regulatory Project Manager” name from the Nov. 23, 2021 Livtencity (maribavir) approval letter.