Gland Pharma, a pharma company focused on generic injectable and ophthalmic products, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection, 2.5 mg/mL.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, GIAPREZA, marketed by La Jolla Pharma LLC.
Gland Pharma’s Angiotensin II Acetate Injection is indicated for increasing blood pressure in adults experiencing septic or other distributive shock.
The company is the exclusive First-to-File applicant for this product and will be eligible for 180 days of generic drug exclusivity in the United States.
According to IQVIA data, the product recorded US sales of approximately USD 58 million for the twelve-month period ending March 2025.