BLA 761184, held by Pfizer Ireland Pharmaceuticals. Somatrogon-Ghla.
As of Nov 14, 2026, BLA 761184 (Ngenla), held by Pfizer Ireland Pharmaceuticals, was first approved by FDA on Jun 27, 2023, with 4 approved supplements and 1 published complete response letter.
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 21, 2022 | MOD-4023Facility Inspections | Approved |
| Ngenla24MG · injectable;injection | Somatrogon-Ghla | Rx |
| Ngenla60MG · injectable;injection | Somatrogon-Ghla | Rx |
| Apr 29, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Jul 9, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Jul 5, 2024 | Supplement 3Manufacturing | Approved | None posted |
| Dec 27, 2023 | Supplement 1Manufacturing | Approved | |
| Jun 27, 2023 | Original applicationNew molecular entity · Standard review | Approved |
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
