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# Complete Response Letter for Eagle Vasopressin ANDA
- URL: https://www.fdaweb.com/complete-response-letter-for-eagle-vasopressin-anda/
- Published: 2021-02-02T12:00:00.000Z
- Updated: 2026-09-14T16:45:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148573

FDA has issued a complete response letter to Eagle Pharmaceuticals for its ANDA for vasopressin. The company [says](ttps://www.businesswire.com/news/home/20210202005379/en/Eagle-Pharmaceuticals-Receives-Additional-FDA-Questions-Regarding-Vasopressin-Court-Date-Set-for-July-7-2021-in-Vasopressin-Trial) it has had two conversations with the agency about the letter and will have an additional meeting with FDA within 30 days.

Eagle says it believes it can respond to questions FDA raised in the letter. It says one additional short-duration study must be completed and analyzed and it should be run in mid-February or March. It says that based on similar studies already run it expects the results to be satisfactory and also says it expects to be awarded 180 days of marketing exclusivity.