Pharmaceutical 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 3 spellings of its name, each linked to the record. See the Eisai group view.
As of Nov 13, 2026, FDA's public records list Eisai and its 3 subsidiaries with 16 drug applications, 1 drug recall, 1 OPDP letter and 1 510(k) clearance. The most recent is an OPDP letter dated Oct 11, 2018: Untitled letter: Fycompa.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Eisai and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 11, 2018 | Untitled letter: FycompaOffice of Prescription Drug Promotion | OPDP letters |
| Dec 5, 2014 | BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, DistClass III · Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/o | Drug recalls |
| Feb 11, 1987 | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*K864835 · FCD | 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
