Alembic Pharma gets FDA approval cholesterol lowering drug

Alembic Pharma gets FDA approval for cholesterol lowering drug

9:53 AM, 13th August 2019
Alembic Pharma logo

VADODARA, INDIA: Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets of AbbVie Inc (AbbVie).

Fenofibrate Tablets USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDLC) in adult patients with primary hypercholesterolernla or mixed dyslipidemia.

It is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Alembic now has a total of 102 ANDA approvals (90 final approvals and 12 tentative approvals) from USFDA.

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