What's the most recent regulatory action in Therapy of hemorrhagic disease of the newborn?

Most recent: Vitamin K1 — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Therapy of hemorrhagic disease of the newborn — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Therapy of hemorrhagic disease of the newborn (disease) competitive landscape: 1 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

1 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Therapy of hemorrhagic disease of the newborn, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	Line of therapy	First approval
Vitamin K1	Phytonadione	Pfizer Inc.	Vitamin K [EPC]	Vitamin K-dependent carboxylase; vitamin K epoxide reductase complex (indirect antagonism of warfarin effects)

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-03-13 — Vitamin K1 · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Pfizer Inc. · 1 drug in Therapy of hemorrhagic disease of the newborn

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Every new regulatory action, PDUFA date, or trial completion in Therapy of hemorrhagic disease of the newborn:

Cite this brief

Drug Landscape (2026). Therapy of hemorrhagic disease of the newborn — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/therapy-of-hemorrhagic-disease-of-the-newborn. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing