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U.S. Department of Health and Human Services

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Abciximab Approval Information - Licensing Action

Proper name: Abciximab
Tradename: ReoPro
Manufacturer: Centocor B.V., Leiden, The Netherlands, License #1178
Indication for Use: Expanded indication to provide for revised dosage and patient management guidelines to reduce bleeding, and to include additional information on readministration. Indication now includes treatment of a broad range of patients undergoing percutaneous coronary intervention and patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
Approval Date: 11/5/97
Type of submission: Biologics license supplement

 


Approval Letter (PDF)

Supervisory Overview 1 (PDF)

Supervisory Overview 2 (PDF)

Labeling (PDF)

Medical Officers Review (PDF)

Clinical Review (PDF)