Gland Pharma gets USFDA approval for Angiotensin II injection with 180-day exclusivity

Gland Pharma has received approval from the USFDA for its Abbreviated New Drug Application for Angiotensin II Acetate Injection, a bioequivalent version of Giapreza by La Jolla Pharma LLC.

HyderabadGland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection.

The product is bioequivalent and therapeutically equivalent to the reference listed drug Giapreza of La Jolla Pharma LLC.

This product is indicated for increasing blood pressure in adults with septic or other distributive shock. Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.

According to IQVIA, the product had US sales of approximately $ 58 million for the twelve months ending March 2025, the Hyderabad-based company said in a release.

Published on June 4, 2025

This article first appeared on The Hindu Business Line

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