FDA Approves Generic Fenofibrate Launch

Aurobindo Pharma Limited has received final approval from the FDA to launch fenofibrate tablets, 48 mg and 145 mg.

Aurobindo’s tablets were determined to be bioequivalent and therapeutically equivalent to Abbvie Inc’s TriCor, according to the Division of Bioequivalence.

The generic may be used to treat patients who have a high cholesterol and triglyceride in their blood.

The market for the 48 mg and 145 mg versions of the fenofibrate tablets is estimated to be around $412 million for the fiscal year ending in March 2016. At the moment, Aurobindo’s portfolio consists of 219 final approvals, including 35 tentative approvals.

A build-up of cholesterol and fats along the walls of the arteries can reduce blood flow. In turn, this can increase the risk of heart disease, strokes, and heart attacks in certain individuals. Fenofibrate can speed up the process that removes cholesterol from the body. However, there is no evidence that it can reduce the risk of heart attacks or strokes.

The most common side effects associated with fenofibrate are constipation, diarrhea, heartburn, and headache. However, some rare side effects may also occur, including weakness, muscle pain, joint pain, and fever. These symptoms should be reported to a physician immediately.