India’s Aurobindo gets USFDA’s OK for its pulmonary tablets ‘Sildenafil’November 23, 2015
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil Tablets, 20 mg (ANDA 203963).
According to the company’s Saturday press release, this product for high blood pressure in the lungs is expected to be launched by Q4 FY 2015-16.
Aurobindo notes that the approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) REVATIO (sildenafil citrate) Tablets 20 mg of Pfizer, Inc.
Market size of $80 billion
Aurobindo says that, according to IMS, the approved product has an estimated market size of $80 million for the twelve months ending September 2015.
This is the 51st ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo adds that in now has a total of 219 ANDA approval.