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Aurobindo Pharma has received approval from the US health regulator to manufacture and market Sildenafil injection, used for treating pulmonary arterial hypertension, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Sildenafil injection in the US market, Aurobindo Pharma Ltd said in a statement.
The company's product is a generic version of pharma major Pfizer's Revatio injection.
Sildenafil injection is indicated for the treatment of adult patients with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
"This is the 9th abbreviated new drug application (ANDA) to be approved out of Unit IV formulation facility in Hyderabad... And will be marketed and sold by Aurobindo's wholly-owned subsidiary AuroMedics Pharma LLC," the company said.
