The official Drugs@FDA dataset lists original submission 1 for BLA 022505 with status AP dated 2010-11-10, and names tesamorelin acetate among the application record's active ingredients. 1
This page reports bounded application metadata attributed to Drugs@FDA. It does not reproduce labeling, describe an indication, compare products, or provide medical guidance. 1
What this source can tell us. PeptideScanner is reporting the cited regulator or label record. The summary does not extend that record into broader safety, effectiveness, or approval claims.