Gland Pharma Gets US FDA Nod For Generic Angiotensin II

Gland Pharma Ltd. on Wednesday said it has secured approval from the US Food and Drug Administration for its abbreviated new drug application for Angiotensin II acetate injection, 2.5 mg/mL. The injection is a generic version of La Jolla Pharma LLC's Giapreza, the company said in a filing.

The drug is used to increase blood pressure in adults with septic or other forms of distributive shock. Gland Pharma is the exclusive first-to-file applicant and will benefit from 180 days of generic drug exclusivity in the US market.

Quoting IQVIA data, the company said the product had US sales of around $58 million for the year ended March.