Infliximab Product Approval Information - Licensing Action

Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA, License #1242
Indication for Use: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)
Approval Date: 8/24/98
Type of submission: Biologics license application

Approval Letter (PDF)

Label (PDF)

Review Documents
      Clinical Review (CBER) (PDF)
      Clinical Review (CDRH) (PDF)
      Clinical Pharmacology (PDF)
      Pharmacology Review (PDF)
      Product Review (PDF)
      Product Review (Attachments 1-8) (PDF)
      Statistical Review (PDF)