Gland Pharma Limited, a leading pharmaceutical company specializing in injectable and ophthalmic products, has received approval from the U.S. 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 deemed bioequivalent and therapeutically equivalent to the reference listed drug, GIAPREZA® by La Jolla Pharma LLC. It is indicated for the treatment of adults with septic or other forms of distributive shock to increase blood pressure.
Notably, Gland Pharma is the exclusive First-to-File applicant for this drug, making it eligible for 180 days of generic market exclusivity in the United States.
According to IQVIA data, the product recorded approximately USD 58 million in U.S. sales over the 12-month period ending March 2025.