- Source : Press Release
- Date : 2019-08-13
- Event type : Approved
- Companies : Alembic Pharmaceuticals Ltd.
Alembic Pharmaceuticals receives USFDA Approval for Fenofibrate Tablets USP, 48 mg and 145 mg
Alembic Pharmaceuticals Limited today announced that the Company has received
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New
Drug Application (ANDA) for Fenofibrate Tablets USP, 48 mg and 145 mg. The
approved ANDA is therapeutically equivalent to the reference listed drug product
(RLD) Tricor Tablets, 48 mg and 145 mg, of AbbVie Inc. (AbbVie). Fenofibrate Tablets,
USP are indicated as adjunctive therapy to diet to reduce elevated low-density
lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and
apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-
C) in adult patients with primary hypercholesterolernla or mixed dyslipidemia. It is also
indicated as adjunctive therapy to diet for treatment of adult patients with severe
hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting
chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the
risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk
has not been adequately studied.
Fenofibrate Tablets USP, 48 mg and 145 mg have an estimated market size of US$
94 million for twelve months ending December 201-8 according to IQVIA.
Alembic now has a total of 102 ANDA approvals (90 final approvals and 12 tentative
approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development
pharmaceutical company, has been at the forefront of healthcare since 1907.
Headquartered in India, Alembic is a publicly listed company that manufactures and
markets generic pharmaceutical products all over the world. Alembic's state of the art
research and manufacturing facilities are approved by regulatory authorities of many
developed countries including the USFDA. Alembic is one of the leaders in branded
generics in India. Alembic's brands, marketed through a marketing team of over 5000
are well recognized by doctors and patients.
Information about the company can be found
at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg:
ALPM) (NSE: APLL TD) (BSE: 533573)
For more information contact:
Ajay Kumar Desai
Phone: 91 22 - 306 11681
Email: ala .desai alembic.co.in
Phone: 91 265 - 3007630
ALEMBIC PHARMACEUTICALS LIMITED
REG~. OFFICE : ALE~BIC ROAD, VADODARA • 390 003. • TEL : (0265) 2280550, 2280880 • FAX : (0265) 2281229
website : www.alemb1cpharmaceuticals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123