Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil Injection, 10mg/12.5mL (0.8mg/mL). This is the 9th ANDA (represented by 7 product classes) to be approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products and will be marketed and sold by Aurobindo’s wholly owned subsidiary AuroMedics Pharma LLC.
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 with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
