SOMAVERTpegvisomant

FDA approved the original biologics license application for SOMAVERT on March 25, 2003, sponsored by PHARMACIA. FDA classed that submission a new molecular entity, which makes it the first approval of pegvisomant in any product. FDA has approved 2 efficacy supplements on the application since, the most recent on July 27, 2023.

Application

BLA021106

Sponsor

PHARMACIA

Original approval

March 25, 2003

Review

priority review

Submission class

Type 1 - New Molecular Entity

Active ingredient

pegvisomant

Browse every approval whose brand starts with S, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 8 · Labeling 8. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to PHARMACIA

• January 30, 2004CADUETNDA021540
• August 24, 1995GENOTROPIN PRESERVATIVE FREEBLA020280
• February 21, 1992MAXAQUINNDA020013