Capromab Pendetide Product Approval Information - Licensing Action

Proper name: Capromab Pendetide
Tradename: ProstaScint
Manufacturer: Cytogen Corp, Princeton, NJ, License #1164
Indication for Use: For the preparation of Indium In 111 Capromab Pendetide to be used as a diagnosing imaging agent in newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized after standard diagnostic evaluation, who are at high risk for pelvic lymph node metasteses, and in post prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease
Approval Date: 10/28/96
Type of submission: Biologics license application

Approval Letter (PDF)

SBA (PDF)

Label (PDF)