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 AlvotechLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Alvotech USA with 6 complete response letters and 2 drug applications. The most recent is a complete response letter dated Nov 26, 2025: Complete response letter, BLA 761461.
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.
| Nov 26, 2025 | Complete response letter, BLA 761461Unapproved | Complete response letters |
| Nov 24, 2025 | Complete response letter, BLA 761435Unapproved | Complete response letters |
| Oct 31, 2025 | Complete response letter, BLA 761462Unapproved | Complete response letters |
| Oct 11, 2023 | Complete response letter, BLA 761343Approved | Complete response letters |
| Jun 28, 2023 | Complete response letter, BLA 761299Approved | Complete response letters |
| Dec 20, 2022 | Complete response letter, BLA 761299Approved | 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
