NDA 208901, held by Mayne Pharma. Itraconazole.
As of Nov 14, 2026, NDA 208901 (Tolsura), held by Mayne Pharma, was first approved by FDA on Dec 11, 2018, with 1 approved supplement and 0 published complete response letters.
TOLSURA is indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tolsura65MG · capsule;oral | Itraconazole | RxReference drug |
| Oct 25, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Dec 11, 2018 | 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
