Treats Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma. NDA 202317, held by Helsinn. Mechlorethamine Hydrochloride.
As of Nov 14, 2026, NDA 202317 (Valchlor), held by Helsinn, was first approved by FDA on Aug 23, 2013, with 8 approved supplements and 0 published complete response letters.
VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ValchlorEQ 0.016% BASE · gel;topical | Mechlorethamine Hydrochloride | RxReference drug |
| May 1, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Jan 13, 2020 | Supplement 9Labeling · Standard review | Approved | |
| Dec 22, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 8, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 29, 2015 | Supplement 4Labeling · Standard review | Approved | |
| Oct 13, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 8, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 23, 2013 | Original applicationNew formulation or manufacturer · 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
