BLA 103608, held by Cytogen. Capromab Pendetide.
As of Nov 13, 2026, BLA 103608 (Prostascint), held by Cytogen, was first approved by FDA on Oct 28, 1996, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prostascint05.MG/ML · vial; intravenous | Capromab Pendetide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2012 | Supplement 5043 | Approved | |
| Oct 28, 1996 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
