Alembic Pharma gets final USFDA nod for Fenofibrate tablets
New Delhi: Alembic Pharmaceuticals on Thursday said it has received final nod from the US health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in the blood. "Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg.
"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc (AbbVie)," the drug firm said in a BSE filing.
Fenofibrate tablets have an estimated market size of USD 100 million for twelve months ending September 2019, according to IQVIA.
"Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia," it said.
Alembic has a cumulative total of 113 ANDA approvals -- 100 final approvals and 13 tentative approvals -- from the USFDA.