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Gland Pharma gets USFDA nod for Angiotensin II Acetate Injection, secures 180-day exclusivity
By Markets Desk Published on June 4, 2025, 08:20 IST
Gland Pharma Limited has received final 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 injectable product is bioequivalent and therapeutically equivalent to the reference listed drug GIAPREZA®, developed by La Jolla Pharma LLC. It is indicated for increasing blood pressure in adults suffering from septic or other distributive shock.
Importantly, Gland Pharma is the exclusive First-to-File applicant for this product and has secured 180 days of generic drug exclusivity in the U.S. market.
According to IQVIA data, US sales of Angiotensin II Acetate Injection stood at approximately USD 58 million for the twelve months ending March 2025, highlighting the commercial opportunity for Gland Pharma.
This approval further strengthens Gland Pharma's injectables portfolio and underscores its regulatory and filing capabilities in complex products.
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