Gland Pharma gets USFDA nod for key injection

Gland Pharma received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA of La Jolla Pharma LLC.

This Product is indicated for increasing the 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 USD 58 million for the twelve months ending March 2025.