Alembic Pharma Gets Final U.S. FDA Nod For Cholesterol Drug
Tablets move along the production line before packaging at a drug manufacturing facility in Russia. Photographer: Andrey Rudakov/Bloomberg  

Alembic Pharma Gets Final U.S. FDA Nod For Cholesterol Drug

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Alembic Pharmaceuticals Ltd. on Thursday said it has received final nod from the U.S. health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in blood.

"Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the U.S. Food & Drug Administration for its Abbreviated New Drug Application Fenofibrate Tablets USP, 54 mg and 160 mg,” the drug firm said in a BSE filing. "The approved ANDA is therapeutically equivalent to the reference listed drug product Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc."

Also read: Alembic Pharma Rises On New Drug Approval From U.S. FDA

Fenofibrate tablets have an estimated market size of $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 U.S. FDA.

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