Aurobindo Pharma Limited on November 21, 2015 announced that the company has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market sildenafil tablet (20 mg). The approved product, which is expected to be launched by Q4 FY 2015-16, is generic version of Pfizer’s Revatio (sildenafil citrate) tablet.
Sildenafil tablet, which is used in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs), has an estimated market size of $ 80 million for the twelve months ending September 2015, according to IMS.
This is the 51st ANDA to be approved out of Aurobindo Pharma’s unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
