Gland Pharma gets U.S. FDA nod for Angiotensin II Acetate Injection

Generic injectable focused Gland Pharma's version of La Jolla Pharma's Giapreza injection for increasing blood pressure in adults with septic or other distributive shock has received U.S. Food and Drug Administration approval.
It is the exclusive first-to-file and consequently eligible for 180 days of generic drug exclusivity, Gland Pharma said on Wednesday, announcing U.S. FDA approval for its abbreviated new drug application related to Angiotensin II Acetate Injection 2.5 mg/mL.
Bioequivalent and therapeutically equivalent to reference listed drug Giapreza of La Jolla Pharma LLC, the product had U.S. sales of around $58 million for the 12 months ended March 2025, Gland Pharma said citing IQVIA numbers. The company's shares closed 1.88% higher at ₹1,623.70 apiece on the BSE.

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