On 15 November, Gland Pharma announced that it had received tentative approval from the USFDA (US Food and Drug Administration) for its Angiotensin II Injection, 2.5 mg/mL Single Dose Vial.
The generic injectable-focused pharmaceutical company believes it is the only company and the first to file for this product, making it eligible for 180 days of generic drug exclusivity.
The drug will be launched with its marketing partner after the company receives final approval from the US regulator.
Angiotensin II increases blood pressure in adult patients and treats low blood pressure with distributive shd septic shock. Angiotensin II Injection, 2.5 mg/mL Single Dose Vial, has US sales of approximately $38 million in twelve months, according to IQVIA.
In its quarterly report for the July-September, the company reported a 19.56% year-on-year (YoY) decline in its net profit to Rs 194 crore during the quarter from Rs 241.2 crore reported in the same quarter of the previous fiscal year.
The pharmaceutical company’s revenue was Rs 1,373.4 crore during the quarter, a 31.52% year-over-year increase from the Rs 1,044.4 crore reported in the same quarter last year.