Etanercept Product Approval Information - Licensing Action 12/2/98

Proper name: Etanercept
Tradename: Enbrel
Manufacturer: Immunex Corp, Seattle, WA, License #1132
Indication for Use: Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDS)
Approval Date: 11/2/98
Type of submission: Biologics license application


Approval Letter (PDF)

Label (PDF)


Review Documents
      Clinical Pharmacokinetics Review (PDF)
      Clinical Review (October 28, 1998) (PDF)
      Clinical Review (December 1, 1998) (PDF)
      CMC Review (PDF)
      Nonclinical Pharmacology and Toxicology Review (PDF)
      Statistical Review (PDF)

Page Last Updated: 04/01/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English