Treats relapsing forms of multiple sclerosis (MS). NDA 22561, held by Emd Serono Inc. Cladribine.
As of Nov 14, 2026, NDA 22561 (Mavenclad), held by Emd Serono Inc, was first approved by FDA on Mar 29, 2019, with 5 approved supplements and 1 published complete response letter.
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. Limitations of Use MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Feb 28, 2011 | NDA 022561Clinical, Product Quality, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mavenclad10MG · tablet;oral | Cladribine | RxReference drug |
| May 14, 2026 | Supplement 13Labeling · Standard review | Approved | |
| May 10, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Feb 7, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Dec 6, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Sep 19, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Mar 29, 2019 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
