NDA 19884, held by Baxter Hlthcare. Mesna.
As of Nov 14, 2026, NDA 19884 (Mesnex), held by Baxter Hlthcare, was first approved by FDA on Dec 30, 1988, with 10 approved supplements and 0 published complete response letters.
MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesnex100MG/ML · injectable;intravenous | Mesna | RxReference drug |
| Dec 17, 2018 | Supplement 16Labeling · Standard review | Approved | |
| Feb 26, 2016 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Mar 17, 2014 | Supplement 13Labeling · Standard review | Approved | |
| Jan 30, 2003 | Supplement 7Labeling · Priority review | Approved | |
| Jan 30, 2003 | Supplement 8Labeling · Standard review | Approved | |
| Jul 26, 2000 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| May 23, 1996 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Sep 25, 1995 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 16, 1994 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Apr 22, 1993 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Dec 30, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
