RecallHawk

OXBRYTA (VOXELOTOR)

GLOBAL BLOOD THERAPS

Summary

FDA approved OXBRYTA (VOXELOTOR) by GLOBAL BLOOD THERAPS. NDA (New Drug) approval (Labeling) on 2023-08-18. TABLET, FOR SUSPENSION, ORAL.

Details

Source

Drug Approval

External ID

NDA216157-3

Action Date

2023-08-18

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

OXBRYTA (generic: VOXELOTOR), TABLET, FOR SUSPENSION, ORAL. Application: NDA216157

Context & Analysis

GLOBAL BLOOD THERAPS has 2 FDA actions in our database.

Frequently Asked Questions

How often does GLOBAL BLOOD THERAPS have FDA actions?

GLOBAL BLOOD THERAPS has 2 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA216157-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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