Gland Pharma has received tentative approval from the United States Food and Drug Administration (US FDA) for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial.

Gland Pharma believes that it is the only company with first to file for this product and may be eligible for 180 days of generic drug exclusivity.

Gland Pharma will launch the product with its marketing partner on receipt of final approval. The Angiotensin II Injection, 2.5 mg/mL Single Dose Vial (RLD: Giapreza Injection) has US sales of approximately USD 38 million for twelve months ending in September 2023, according to IQVIA.