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# FDA Tentatively Approves Vasopressin ANDA
- URL: https://www.fdaweb.com/fda-tentatively-approves-vasopressin-anda/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150808

FDA has tentatively approved an Amphastar ANDA for vasopressin injection, 20 units/mL, 1 mL single-dose vial, indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. *BioSpace* [reports](https://www.biospace.com/article/releases/amphastar-receives-fda-tentative-approval-for-vasopressin/?ref=fdaweb.com) that the agency determined that the Amphastar product is bioequivalent and therapeutically equivalent to Par’s Vasostrict.

The report says the timing of Amphastar’s commercialization of its vasopressin product depends on the undisclosed terms of a settlement agreement with Par and FDA final approval.