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ngenla

Generic: somatrogon-ghla·Code: hGH-CTP

ngenla: developed by 2 companies · 1 FDA decision.

ngenla evidence translation

What we can confirm

1 FDA record

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about ngenla, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

growth disturbance due to insufficient secretion of growth hormone

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (3)
CompanyPhase
OPKO HEALTH, INC. (OPK)
growth disturbance due to insufficient secretion of growth h…
Approved
PFIZER INC (PFE)Approved
PFIZER INC (PFE)Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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 ( 1 ).(PFE)FDA ↗
BLA761184Type 1 - New Molecular EntityOrphan DrugStandardOtherInjectable

Frequently asked questions

Who is developing ngenla?

ngenla is being developed by OPKO HEALTH, INC., PFIZER INC.

What is ngenla's latest FDA decision?

The most recent tracked FDA decision for ngenla is Approval for 1 INDICATIONS AND USAGE 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 ( 1 )., dated June 27, 2023.