Aurobindo Pharma 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 Q4FY 2015-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) REVATIO (sildenafil citrate) Tablets 20 mg of Pfizer, Inc.
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 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. The pharma major now has a total of 219 ANDA approvals (190 Final approvals including 10 from Aurolife Pharma LLC and 29 Tentative approvals) from USFDA.
Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
