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Amgen

Biotech companyAI in United StatesAI. FDA records under 8 spellings of its name, each linked to the record. See the Amgen group view.

  • Records across the group: 67, 11 entitiesAI
  • Drug applications: 46
  • Drug recalls: 12
  • Complete response letters: 3
  • 510(k) clearances: 3

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Amgen and its 10 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Aug 12, 2026Warning letter: VectibixOffice of Prescription Drug PromotionOPDP letters
Jun 4, 2026Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60Class II · Presence of Foreign Substance.Drug recalls
Jun 4, 2026Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx OClass II · Presence of Foreign Substance.Drug recalls
Jun 4, 2026Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Class II · CGMP DeviationsDrug recalls
Jun 4, 2026Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Class II · CGMP DeviationsDrug recalls
Jun 4, 2026Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Class II · CGMP DeviationsDrug recalls
Sep 9, 2025Untitled letter: IMDELLTRAOffice of Prescription Drug PromotionOPDP letters
Feb 27, 2025Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile SolutioClass II · Stability data does not support expiry: the products have the potential to be out of specification at the time of expiryDrug recalls
Feb 27, 2025Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use OnClass II · Stability data does not support expiry: the products have the potential to be out of specification at the time of expiryDrug recalls
May 2, 2022MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Class II · Defective container: loose crimp defect, potential loss of container integrity.Drug recalls
Jul 7, 2021Untitled letter: NeulastaOffice of Prescription Drug PromotionOPDP letters
May 25, 2018Complete response letter, BLA 761073ApprovedComplete response letters
Jul 13, 2017Complete response letter, BLA 761062ApprovedComplete response letters
Aug 27, 2015Complete response letter, BLA 125522ApprovedComplete response letters
Oct 10, 1989CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3K894943 · GGT510(k) clearances
Dec 20, 1988ERYTHROPOIETIN ENZYME IMMUNOASSAYK882686 · GGT510(k) clearances
Aug 31, 1981HUMAN C-PEPTIDE REAGENTSK812288 · JKD510(k) clearances

Subsidiaries and Divisions

10 firms in the Amgen group, most records first

Canada and Imports

Across the Amgen group, matched by company name
FDA import refusals since 2024
11 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
AMGEN INCAmgen, Inc.AMGENAmgen Inc.Amgen
Website
amgen.com
Wikidata
Q470517

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.