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)

SBA (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)