Alembic Pharmaceuticals receive USFDA nod for Fenofibrate tablets

Alembic Pharmaceuticals announced that it has received a final approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibrate tablets USP, 54 mg and 160 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Tricor tablets, 54 mg and 160 mg of AbbVie Inc.

The approved drug has an estimated market size of US$ 100 million for twelve months ending September 2019, according to IMS Health and Quintiles (IQVIA). It is indicated as a supplementary to diet to reduce elevated LDL-C, Total-C, TG and Apo B and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia.

Alembic Pharmaceuticals engages in developing formulations and Active Pharmaceutical Ingredients (API). The company focusses on anti-infective, analgesic, cough and cold therapies. The company has a cumulative total of 113 ANDA approvals from USFDA.

On Thursday the stock closed at 590.05, up by 0.05 per cent or Rs 0.30 per share. The 52-week high is recorded at Rs 611.45 and the 52-week low is recorded at Rs 435.10 on BSE.