A bottle of generic tablets produced by an Indian pharma firm. (Photographer: Dhiraj Singh/Bloomberg)

Alembic Pharma Rises On New Drug Approval From U.S. FDA

Drug maker Alembic Pharmaceuticals Ltd. has received approval from the U.S. health and food regulator for Fenofibric acid delayed-release capsules, the company said in a company filing with exchanges.

This drug is used to treat high cholesterol levels in the blood.

The company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric in the strengths of 45 mg and 135 mg.
Alembic Pharmaceuticals Press Release

The tablet had an estimated market size of $93 million in the U.S., as of December 2016, according to IMS Health, an integrated information and technology company specialising in healthcare.

The approved products are therapeutically equivalent to the reference listed drug products Trillipix, which is used to treat high blood pressure and cholesterol, said the company in its press release.

This approval takes the company’s ANDA tally to 56, of which 50 are final approvals.

The drug-maker’s share gained as much as 3.25 percent in morning trade on Monday, the highest since March 2017 to Rs 618 on the BSE.