Drugs / Epogen
Epogen
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | EPOGEN/PROCRIT | — | 1993-04-01 – 2011-06-24 | fda.gov ↗ |
| Approved | US (FDA) | EPOGEN/PROCRIT | — | 1989-06-01 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT01170078 Comparator | Jul 2010 → Jan 2011 | chronic renal failure syndrome | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00924781 Background | Jun 2009 → Apr 2010 | anemia, chronic kidney disease | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01473407 Comparator | Jan 2012 → Feb 2014 | chronic renal failure syndrome | Pfizer | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-05-15 | Pfizer | Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA pfizer.com ↗ |
| 2017-05-25 | Pfizer | FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Epogen®/Procrit® Across All Indications pfizer.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epogen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01473407 ↗ |
| Known as | epoetin alfa | “Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline.” NCT00924781 ↗ |
| Known as | Epoetin Alfa (Amgen) | “This study assessed the comparability of the pharmacokinetics (PK) of epoetin following intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in...” NCT01170078 ↗ |
| Modality | Protein / enzyme biologic | “Biological: Epogen (Amgen)” NCT01473407 ↗ |
| Route | Intravenous | “receive either Epoetin Hospira or Epogen (Amgen) by intravenous (IV) bolus injections administered three times a week for 1 week.” NCT01170078 ↗ |