Treats relapsing forms of multiple sclerosis (MS). ANDA 215547, held by Hopewell Pharma. Cladribine.
As of Nov 14, 2026, ANDA 215547 (Cladribine), held by Hopewell Pharma, was first approved by FDA on Mar 27, 2026, with 0 approved supplements and 0 published complete response letters.
Cladribine 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 cladribine 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2026 | Original application | Approved | None posted |
| 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
