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Aurobindo Pharma Limited today announced that it has received final approvals from the US Food and Drug Administration(USFDA) to manufacture and market Sildenafil injection.
The drug is bioequivalent and therapeutically equivalent to the reference listed drug product Revatio (sildenafil) Injection of Pfizer, the company said. It 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, it said.
This is the ninth Abbreviated New Drug Application (ANDA) represented by 7 product classes to be approved out of Unit 5 formulations facility of the company in Hyderabad. The product will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, according to a press release.
