Pharma Focus Asia

Alembic Pharmaceuticals receives USFDA Approval for Fenofibric Acid Delayed-Release Capsules

Monday, May 15, 2017

Alembic Pharmaceuticals limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trilipix Delayed-Release Capsules, 45 mg and 135 mg, of Abbvie Inc. Fenofibric Acis Delayed-Release Capsules are indicated as an adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia and to reduce elevated LDL-C, total cholesterol (Total-C), TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia.

Fenofibric Acid Delayed-Release Capsules have an estimated market size of US$ 93 million for twelve months ending December 2016 according to IMS.

Alembic now has a total of 56 ANDA approvals (50 final approvals and 6 tentative approvals) from USFDA.

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