Alembic Pharmaceuticals has received approval from the US health regulator for its Fenofibric Acid Delayed Release capsules used for lowering high cholesterol and increasing good cholesterol, the company said on Monday, helping the stock to jump 3.2% in intra-day trade.
The drug have an estimated market size of $93 million for 12 months to December 2016, according to IMS.
“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 informed the Bombay Stock Exchange.
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.
The approved product is therapeutically equivalent to the reference listed drug product Trilipix Delayed-Release capsules of Abbvie Inc.
Alembic Pharma has a total of 56 ANDA approvals from the US health regulator.
The stock rose as much as 3.2% to Rs 619 in early trade at the BSE but gave away gains by noon.
(With inputs from PTI)
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