Aurobindo Pharma receives US FDA Approval for Sildenafil injection

Sildenafil injection is indicated for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are temporarily unable to take oral therapy

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Sildenafil injection, 10mg/12.5mL (0.8mg/mL) (ANDA 203988).

Sildenafil injection 10mg/12.5mL (0.8mg/mL) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD), Revatio (sildenafil) injection, 10 mg/12.5 mL (0.8 mg/mL), of Pfizer. Sildenafil injection is indicated for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.

This is the 9th ANDA (represented by seven 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.