Labeler · US market

Akebia Therapeutics, Inc.

Akebia Therapeutics, Inc. is a US drug labeler with US FDA registrations covering 2 drug concepts (2 currently active) across 4 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes59922

Active drugs2

Registrations4 active / 4

Packages4

Sole supplier of1 drugs

Portfolio2 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Vadadustat tablet, film coated	rx	3	3	SUPPLYING
Ferric Citrate tablet, film coated	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Vadadustatrx

At a glance

TypeLabeler
Labeler codes59922
Filing names1
Drugs (active)2
Drugs (all time)2
US registrations4
Packages4

Recent events

Shortages, recalls, and registration changes across all filing names.

Dec 9, 2020
RECALLRecall (Class II): Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHA…
Jul 10, 2020
RECALLRecall (Class II): Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Bi…
Dec 12, 2017
RECALLRecall (Class III): Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Bioph…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.