Quick answers
- What is Cladribine used for?
- The FDA-approved label (Mavenclad, EMD Serono, Inc., May 27, 2026) says: “MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cladribine have a boxed warning?
- Yes. The FDA label for Mavenclad has a boxed warning (“WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cladribine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cladribine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cladribine?
- 7 companies list prescription products of Cladribine in the FDA NDC Directory, including Hisun Pharmaceuticals USA, Inc., Hikma Pharmaceuticals USA Inc. and Fresenius Kabi USA, LLC.
What Cladribine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS […]. …
— FDA label: Mavenclad, EMD Serono, Inc., effective May 27, 2026. Read the full label on DailyMed →
The FDA has 8 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.
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.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Injection |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Mavenclad |
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.
- Hisun Pharmaceuticals USA, Inc.2 products
- Hikma Pharmaceuticals USA Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Sandoz Inc1 product
- EMD Serono, Inc.1 product
- Apotex Corp.1 product
- Genvion Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022561 MAVENCLAD | Emd Serono Inc | March 29, 2019 | 5, latest May 14, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (5)
- ANDA075405Hikma · February 28, 2000
- ANDA076571Fresenius Kabi USA · April 22, 2004
- ANDA210856Hisun Pharm Hangzhou · November 25, 2019
- ANDA218425Apotex · November 24, 2025
- ANDA215547Hopewell Pharma · March 27, 2026
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) — Mavenclad, EMD Serono, Inc., effective May 27, 2026; 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 →