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Prescription medicine

Voxelotor

Drug class: Hemoglobin S Polymerization Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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.

Quick answers

What is Voxelotor used for?
The FDA-approved label (Oxbryta, Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc., December 26, 2023) says: “OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) […]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Voxelotor have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Voxelotor?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Voxelotor been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Voxelotor?
1 company lists prescription products of Voxelotor in the FDA NDC Directory, including Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc..

What Voxelotor is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) […]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). …

— FDA label: Oxbryta, Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc., effective December 26, 2023. Read the full label on DailyMed →

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

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet, for suspension
RouteOral
Prescription products3 in the FDA NDC Directory
Brand namesOxbryta

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

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA213137
OXBRYTA
Global Blood TherapsNovember 25, 2019 2, latest August 18, 2023
2023: Labeling · 2021: Efficacy
NDA216157
OXBRYTA
Global Blood TherapsDecember 17, 2021 1, latest August 18, 2023
2023: 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

RxCUI (RxNorm)2265683, 2265689, 2588070, 2588074, 2619427, 2619428
SPL set ID of the quoted label3c557fac-29ec-483f-b691-8a935d4decc3
FDA labels (SPL)1
FDA applicationsNDA213137, NDA216157
Active ingredients (FDA)VOXELOTOR

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Oxbryta, Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc., effective December 26, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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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