Somavert

Treats acromegaly. BLA 21106, held by Pharmacia. Pegvisomant.

As of Nov 14, 2026, BLA 21106 (Somavert), held by Pharmacia, was first approved by FDA on Mar 25, 2003, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2003
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jul 27, 2023	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 10, 2013	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 25, 2003	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Products

5 strengths and forms


Somavert10MG/VIAL · injectable;subcutaneous	Pegvisomant	Rx
Somavert15MG/VIAL · injectable;subcutaneous	Pegvisomant	Rx
Somavert20MG/VIAL · injectable;subcutaneous	Pegvisomant	Rx
Somavert25MG/VIAL · injectable;subcutaneous	Pegvisomant	Rx
Somavert30MG/VIAL · injectable;subcutaneous	Pegvisomant	Rx

All 19 submissions, including labeling and manufacturing supplements


Jul 27, 2023	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 20, 2021	Supplement 68Labeling · Standard review	Approved	Letter Label
Aug 20, 2021	Supplement 67Labeling · Standard review	Approved	Label
Sep 24, 2019	Supplement 45Labeling · Standard review	Approved	Letter
Sep 19, 2019	Supplement 64Labeling · Standard review	Approved	Letter Label
Aug 16, 2019	Supplement 55Labeling · Standard review	Approved	Letter Label
Apr 22, 2016	Supplement 50Manufacturing · Priority review	Approved	None posted
Feb 22, 2016	Supplement 46Manufacturing · Priority review	Approved	None posted
Jan 11, 2016	Supplement 48Manufacturing · Priority review	Approved	None posted
Jul 31, 2014	Supplement 44Manufacturing · Priority review	Approved	None posted
Dec 10, 2013	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 11, 2013	Supplement 43Manufacturing · Priority review	Approved	None posted
Sep 26, 2013	Supplement 42Manufacturing · Priority review	Approved	None posted
Mar 1, 2013	Supplement 39Manufacturing · Priority review	Approved	None posted
Jul 3, 2012	Supplement 31Labeling	Approved	Label
Jul 20, 2010	Supplement 28Labeling	Approved	Letter Label
Oct 3, 2008	Supplement 16Manufacturing	Approved	None posted
Aug 18, 2008	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 25, 2003	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Identifiers

Application: BLA 21106
Drugs@FDA: Overview at FDA
Company: Pharmacia

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters