Omnitrope

Treats growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome…. BLA 21426, held by Sandoz. Somatropin.

As of Nov 13, 2026, BLA 21426 (Omnitrope), held by Sandoz, was first approved by FDA on May 30, 2006, with 19 approved supplements and 0 published complete response letters.

First approved: May 30, 2006
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OMNITROPE is a recombinant human growth hormone indicated for:

Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature
Adult: Treatment of adults with either adult onset or childhood onset GHD 1.1 Pediatric Patients OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). OMNITROPE is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 22, 2011	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 26, 2010	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2010	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 23, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
May 30, 2006	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter Other

Products

4 strengths and forms

Product	Active ingredient	Marketing
Omnitrope5.8MG/VIAL · injectable;injection	Somatropin	Rx
Omnitrope1.5MG/VIAL · injectable;injection	Somatropin	Rx
Omnitrope5MG/1.5ML · injectable;injection	Somatropin	Rx
Omnitrope10MG/1.5ML · injectable;injection	Somatropin	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 9, 2025	Supplement 62Labeling · Standard review	Approved	Letter Label
Nov 12, 2024	Supplement 58Labeling · Standard review	Approved	Letter
Nov 12, 2024	Supplement 43Labeling · Standard review	Approved	Letter Label
Jan 25, 2022	Supplement 50Manufacturing	Approved	Letter
Feb 15, 2017	Supplement 22Labeling · Standard review	Approved	Label
Dec 13, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
Aug 29, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 14, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 22, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 18, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 4, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 22, 2011	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 13, 2011	Supplement 18Labeling	Approved	Label Letter
Aug 26, 2010	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 23, 2010	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 23, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Mar 25, 2009	Supplement 6Manufacturing	Approved	Letter Label
Aug 25, 2008	Supplement 4Manufacturing	Approved	Letter Label Review
Jan 16, 2008	Supplement 2Manufacturing	Approved	Letter Label Review
May 30, 2006	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter Other

Identifiers

Application: BLA 21426
Drugs@FDA: Overview at FDA
Company: Sandoz

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