Aurobindo Pharma receives FDA approval for Fenofibrate Tablets
May 09, 2016 | Monday | News | By BioSpectrum Bureau
Aurobindo Pharma receives FDA approval for Fenofibrate Tablets
The drug id generic version of Tricor Tablets of AbbVie
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg. This 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.
Fenofibrate Tablet is used to treat high level of cholesterol and triglyceride in the blood. The approved product has an estimated market size of $412 million for the twelve months ending March 2016 according to IMS.
