Amphastar Receives FDA Approval for Vasopressin

RANCHO CUCAMONGA, CA / ACCESSWIRE / July 19, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Vasopressin injection, USP 20 Units/mL, 1mL Single Dose Vial. In December 2021, the Company had received FDA tentative approval for the ANDA. Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. The FDA determined that Amphastar's vasopressin is bioequivalent and therapeutically equivalent to Par Sterile Products LLC's VASOSTRICT^® (Vasopressin Injection, USP).

According to IQVIA, the U.S. brand and generic sales for vasopressin injection, USP, 20 Units/mL, 1mL, were approximately $714 million for the 12 months ended March 31, 2022.

Amphastar plans to launch its vasopressin product in the coming weeks.

Pipeline Information

The Company currently has three ANDAs on file with the FDA targeting products with a market size of approximately $3.3 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and eight generic products in development targeting products with a market size of approximately $9 billion. This market information is based on IQVIA data for the 12 months ended March 31, 2022. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a bio pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at www.amphastar.com .