Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Sanofi. FDA records under its name, each linked to the record. See the Sanofi group view.
As of Nov 15, 2026, FDA's public records list Bioverativ USA, Inc. with 1 complete response letter. The most recent is a complete response letter dated Nov 13, 2020: Complete response letter, BLA 761164.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 13, 2020 | Complete response letter, BLA 761164Approved | Complete response letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
