USFDA grants approval to Aurobindo Pharma's sildenafil injection

Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market sildenafil injection, 10mg/12.5mL (0.8mg/mL). Sildenafil injection is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD), Revatio injection of Pfizer. 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 ninth ANDA (represented by 7 product classes) to be approved out of unit IV formulation facility in Hyderabad for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC.