Aurobindo Pharma Ltd has announced that the company 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 10mg/12.5mL (0.8mg/mL) is a bioequivalent and therapeutically equivalent to the reference listed drug product, 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 (Abbreviated New Drug application) 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, the company said in a press release.
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