Latest News | Alembic Pharma Gets USFDA Nod for Cholesterol Lowering Drug

New Delhi, Oct 21 (PTI) 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.

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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.

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Quoting IQVIA, Alembic Pharma said Fenofibrate capsules USP, 67 mg, 134 mg and 200 mg have an estimated market size of USD 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.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)