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As of Nov 13, 2026, NDA 18285 (Visken), held by Novartis, was first approved by FDA on Sep 3, 1982, with 32 approved supplements and 0 published complete response letters.
First approved: Sep 3, 1982
Review: Standard
Supplements approved: 32
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 33 submissions below
Date
Submission
Status
Documents
Jun 2, 1983
Supplement 3Efficacy (new indication or use)
Approved
None posted
Sep 3, 1982
Original applicationNew molecular entity · Standard review
Approved
None posted
Products
2 strengths and forms
Product
Active ingredient
Marketing
Visken5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral
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
