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As of Nov 14, 2026, NDA 16968 (Miostat), held by Alcon, was first approved by FDA on Sep 28, 1972, with 20 approved supplements and 0 published complete response letters.
First approved: Sep 28, 1972
Review: Priority
Supplements approved: 20
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE: Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.
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
