Treats relapsing forms of multiple sclerosis (MS). ANDA 218425, held by Apotex. Cladribine.
As of Nov 14, 2026, ANDA 218425 (Cladribine), held by Apotex, was first approved by FDA on Nov 24, 2025, with 0 approved supplements and 0 published complete response letters.
Cladribine tablets are 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 cladribine tablets 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 Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 24, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cladribine10MG · tablet;oral | Cladribine | Rx |
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
