fdaoutsideweb

FDA green-lights Alembic’s cholesterol drug

pharmafile | May 15, 2017 | News story | Sales and Marketing |  Alembic, FDA, cholesterol 

Alembic Pharmaceuticals has announced that its fenofibric acid delayed-release capsules have been approved by the FDA for reducing high cholesterol and increasing good cholesterol.

The capsules are indicated as supplementary to primary therapy in the treatment of high triglyceride in patients with hypertriglyceridemia, as well as to lower high LDL-C levels, total cholesterol, and to increase high-density lipoprotein – also known as ‘good’ cholesterol.

The firm revealed the news via a statement which read: “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.” The capsules are therapeutically equivalent to Abbvie’s Trilipix, the reference listed drug product.

Advertisement

The capsules were approved under an abbreviated new drug application with the FDA; Alembic currently has 56 such approvals with the regulator.  

Matt Fellows

Related Content

FDA grants De Novo authorisation to light-filtering device for migraine

The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Avulux, …

EndoCyclic New Drug application approved by US FDA for endometriosis treatment

EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

The Gateway to Local Adoption Series

Latest content