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Alembic Pharma gets USFDA nod for cholesterol lowering drug

PTI New Delhi | Updated on October 21, 2020 Published on October 21, 2020

Drug firm Alembic Pharma on Wednesday said it has received approval from the US health regulator for Fenofibrate capsules, which reduces cholesterol and triglycerides in blood.

The approved product is therapeutically equivalent to the reference listed drug product Tricor Micronized Capsules of AbbVie Inc.

In a regulatory filing, Alembic Pharma said it has “received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate capsules USP in the strengths of 67 mg, 134 mg and 200 mg.”

Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipideniia.

Quoting IQVIA, Alembic Pharma said Fenofibrate capsules USP, 67 mg, 134 mg and 200 mg have an estimated market size of $17 million for 12 months ending June 2020.

Alembic Pharma has a cumulative total of 133 ANDA approvals (115 final approvals and 18 tentative approvals) from USFDA.

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Published on October 21, 2020
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