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Aurobindo Pharma Ltd has announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil tablets, 20 mg.
This product is expected to be launched by Q4 FY 2015-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product REVATIO (sildenafil citrate) tablets 20 mg of Pfizer Inc, Aurobindo informed the BSE.
Sildenafil tablets are used in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs). The approved product has an estimated market size of $80 million for the 12 months ended September 30, 2015.
This is the 51st ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for the manufacture of oral non-antibiotic products. Aurobindo now has 219 ANDA approvals (190 final approvals, including 10 from Aurolife Pharma LLC and 29 Tentative approvals) from USFDA.
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