FDA green-lights Alembic's cholesterol drug

Alembic Pharmaceuticals has announced that its fenofibric acid delayed-release capsules have been approved by the FDA for reducing high cholesterol and increasing good cholesterol.

The capsules are indicated as supplementary to primary therapy in the treatment of high triglyceride in patients with hypertriglyceridemia, as well as to lower high LDL-C levels, total cholesterol, and to increase high-density lipoprotein – also known as ‘good’ cholesterol.

The firm revealed the news via a statement which read: "The company has received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for its Fenofibric Acid Delayed-Release Capsules, 45mg and 135mg." The capsules are therapeutically equivalent to Abbvie’s Trilipix, the reference listed drug product.

The capsules were approved under an abbreviated new drug application with the FDA; Alembic currently has 56 such approvals with the regulator.  

Matt Fellows