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Prescription medicine

Lonapegsomatropin-tcgd

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Lonapegsomatropin-tcgd key facts

Prescription or over the counter
Prescription (Rx)
Generic available
No generic listed by the FDA
Latest FDA recall
None listed

Sources: FDA NDC Directory (October 30, 2026); FDA enforcement reports (October 27, 2026). Not medical advice.

Quick answers

Is there a shortage of Lonapegsomatropin-tcgd?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Lonapegsomatropin-tcgd been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Lonapegsomatropin-tcgd?
1 company lists prescription products of Lonapegsomatropin-tcgd in the FDA NDC Directory, including Ascendis Pharma Endocrinology, Inc.

What Lonapegsomatropin-tcgd is used for

We did not find an “Indications and Usage” section in the FDA labels for this medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Forms and how it is given

Dosage formsInjection, powder, lyophilized, for solution
RouteSubcutaneous
Prescription products14 in the FDA NDC Directory
Brand namesSkytrofa

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA761177
SKYTROFA
Ascendis Pharma Encocrinology Div A/SAugust 25, 2021 3, latest July 25, 2025
2025: Efficacy · 2025: Labeling · 2022: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

FDA labels (SPL)0
FDA applicationsBLA761177
Active ingredients (FDA)LONAPEGSOMATROPIN

Next steps

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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