Aurobindo Pharma has received final approval from the USFDA to manufacture and market Fenofibrate tablets, used for the treatment of high level of cholesterol, in the American market.
“The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg,” Aurobindo Pharma said in a BSE filing.
The product is expected to be launched in the first quarter of this fiscal.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Tricor tablets of AbbVie Inc, it added.
According to IMS, the approved product has an estimated market size of USD 412 million for the twelve months ended March 2016, Aurobindo Pharma said.
Fenofibrate Tablet is used for the treatment of high cholesterol level and triglyceride in the blood.
Aurobindo Pharma has a total of 259 ANDA approvals (222 final approvals including 11 from Aurolife Pharma LLC and 37 tentative approvals) from the US.
Aurobindo Pharma shares were trading 0.43 per cent down at Rs 801.75 on BSE.