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.. FDA records under 5 spellings of its name, each linked to the record. See the Biogen group view.
As of Nov 13, 2026, FDA's public records list Biogen and its 2 subsidiaries with 12 drug applications, 2 510(k) clearances, 2 drug recalls and 1 complete response letter. The most recent is a complete response letter dated Sep 22, 2025: Complete response letter, NDA 209531/S-016.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Biogen and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 22, 2025 | Complete response letter, NDA 209531/S-016Unapproved | Complete response letters |
| Dec 9, 2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured fClass II · Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testin | Drug recalls |
| Jun 23, 2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142,Class III · cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | Drug recalls |
| Nov 22, 2004 | SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGEK042314 · FMF | 510(k) clearances |
| Nov 5, 2003 | INVISIJECT RESUSABLE AUTO-INJECTORK032425 · KZH | 510(k) clearances |
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
