- The U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals' ( NASDAQ: AMPH ) generic vasopressin injection.
- Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines, the company said in a July 19 press release.
- The company added that in December 2021 it received FDA tentative approval for the ANDA abbreviated new drug application for vasopressin USP 20 Units/mL, 1mL Single Dose Vial.
- The FDA determined that Amphastar's vasopressin was bioequivalent and therapeutically equivalent to Par Sterile Products's Vasostrict (Vasopressin Injection, USP).
- The company said it will launch the product in the coming weeks.
- AMPH +3.54% to $38 premarket July 19
For further details see:
Amphastar generic vasopressin for increasing blood pressure gets FDA approval