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As of Nov 14, 2026, ANDA 206992 (Mesna), held by Gland, was first approved by FDA on Dec 18, 2017, with 2 approved supplements and 0 published complete response letters.
First approved: Dec 18, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
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
