Gland Pharma gets USFDA nod for generic injectable

Gland Pharma gets USFDA nod for generic injectable

New Delhi, Nov 15 (PTI) Gland Pharma on Wednesday said it has received approval from the US health regulator to market a generic product used to raise blood pressure.

The Hyderabad-based company has received tentative approval from the US Food and Drug Administration (USFDA) for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial, it said in a regulatory filing.

The company 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, it added.

Gland Pharma will launch the product with its marketing partner on receipt of final approval, it said.

According to IQVIA data, Angiotensin II Injection (2.5 mg/mL Single Dose Vial) has US sales of around USD 38 million for twelve months ended in September 2023.

Shares of drug firm were trading 0.68 per cent down at Rs 1,613.35 apiece on the BSE. PTI MSS SHW

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