Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg. Fenofibrate Tablet is used to treat high level of cholesterol and triglyceride in the blood. Product is expected to be launched in Q1 FY16-17.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tricor® Tablets of AbbVie Inc. This is the 75th ANDA (including 16 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 259 ANDA approvals (222 Final approvals including 11 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.
The approved product has an estimated market size of US$ 412 million for the twelve months ending March 2016 according to IMS.