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As of Nov 13, 2026, NDA 17697 (Kinevac), held by Bracco, was first approved by FDA on Jul 21, 1976, with 21 approved supplements and 0 published complete response letters.
First approved: Jul 21, 1976
Review: Priority
Supplements approved: 21
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.
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
