Somatrogon-Ghla

Sold as Ngenla. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Somatrogon-Ghla (sold as Ngenla), first approved Jun 27, 2023, with 0 new uses approved and 1 published complete response letter.

First approved: Jun 27, 2023
Applications: 1
New uses approved: 0
Complete response letters: 1
Orphan exclusivity until: Jun 27, 2030
First approved in the EU: Feb 14, 2022
First approved in Japan: Jan 20, 2022

Who Was in the Trials

224 participants in the largest population FDA reports for the Jun 27, 2023 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 28%
65 and older: Not reported
White: 75%
Black: 0%
Asian: 20%
Hispanic or Latino: 11%

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of growth hormone deficiencyPfizer Ireland Pharmaceuticals · designated Sep 29, 2010 · approved Jun 27, 2023 · exclusive to Jun 27, 2030

Approvals in the EU (EMA)

First approved in the EU 16 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ngenla, new substancePfizer Europe MA EEIG · Feb 14, 2022

Approvals in Japan (PMDA)

First approved in Japan 17 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Ngenla, new ingredientDrugs with a new active ingredient indicated for the treatment of short stature due to growth hormone deficiency prior to epiphyseal closure. · Pfizer Japan Inc. · Jan 20, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jun 27, 2023	NgenlaBLA 761184 · New molecular entity	Pfizer Ireland Pharmaceuticals	4	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jan 21, 2022	MOD-4023Facility Inspections	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA