New Delhi: Aurobindo Pharma today received final approval from the USFDA to manufacture and market generic version of Pfizer’s Revatio (sildenafil citrate) tablets used in the treatment of high blood pressure in lungs.
“The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil Tablets, 20 mg”, Aurobindo Pharma said in a BSE filing.
The product is expected to be launched in the fourth quarter of the current fiscal, the statement said.
“The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to Pfizer’s Revatio Tablets 20 mg”, the company added.
Sildenafil Tablets are used in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs).
Quoting IMS data, Aurobindo Pharma said the approved product has an estimated market size of USD 80 million for the twelve months ended September 2015.
This is the 51st ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing Oral Non-Antibiotic products, the company added.
Aurobindo now has a total of 219 ANDA approvals from the USFDA.