Quick answers
- What is Cysteamine bitartrate used for?
- The FDA-approved label (Cystagon, Mylan Pharmaceuticals Inc., August 16, 2021) says: “CYSTAGON ® is indicated for the management of nephropathic cystinosis in children and adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cysteamine bitartrate have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cysteamine bitartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cysteamine bitartrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cysteamine bitartrate?
- 2 companies list prescription products of Cysteamine bitartrate in the FDA NDC Directory, including Horizon Therapeutics USA, Inc. and Mylan Pharmaceuticals Inc..
What Cysteamine bitartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYSTAGON ® is indicated for the management of nephropathic cystinosis in children and adults.
— FDA label: Cystagon, Mylan Pharmaceuticals Inc., effective August 16, 2021. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Horizon Therapeutics USA, Inc.4 products
- Mylan Pharmaceuticals Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020392 CYSTAGON | Mylan | August 15, 1994 | 9, latest June 6, 2016 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2007: Labeling |
| NDA203389 PROCYSBI | Horizon | April 30, 2013 | 18, latest February 11, 2022 2022: Labeling · 2020: Labeling · 2019: Labeling |
| NDA213491 PROCYSBI | Horizon | February 14, 2020 | 1, latest February 11, 2022 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cystagon, Mylan Pharmaceuticals Inc., effective August 16, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →