Alembic Pharma’s cholesterol drug gets US FDA nod
Alembic Pharmaceuticals receives approval from the USFDA for Fenofibric Acid Delayed-Release capsules used for lowering high cholesterol
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New Delhi: Alembic Pharmaceuticals has received approval from the US health regulator for Fenofibric Acid Delayed-Release capsules used for lowering high cholesterol and increasing good cholesterol.
“The company has received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for its Fenofibric Acid Delayed-Release Capsules, 45mg and 135mg,” Alembic Pharma said in a BSE filing on Monday.
The approved product is therapeutically equivalent to the reference listed drug product Trilipix Delayed-Release capsules of Abbvie Inc. Fenofibric Acid Delayed-Release capsules are indicated as an adjunctive therapy to diet to reduce triglyceride (TG) in patients with hypertriglyceridemia and reduce elevated LDL-C, total cholesterol, and increase high-density lipoprotein (HDL) (good) cholesterol levels.
These capsules have an estimated market size of $93 million for 12 months to December 2016, according to IMS. Alembic Pharma has a total of 56 ANDA approvals from the US health regulator. The stock was trading 0.83 % lower at Rs595.75 per on the BSE.