NEW DELHI, Aug 13: Drug firm Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator for Fenofibrate tablets, used to lower cholesterol.
The approved product is therapeutically equivalent to the reference listed drug Tricor tablets of AbbVie Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate tablets in the strengths of 48 mg and 145 mg, Alembic Pharmaceuticals said in a BSE filing.
Quoting IQVIA data, Alembic Pharmaceuticals said Fenofibrate tablets has an estimated market size of USD 94 million for twelve months ending December 2018.
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
It is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.
The company currently has a total of 102 ANDA approvals (90 final approvals and 12 tentative approvals) from the USFDA, it added.