Chennai Bulletin

Chennai Bulletin
கொலஸ்ட்ரால் குறைக்கும் மருந்துக்கு அலெம்பிக் பார்மா யு.எஸ்.எஃப்.டி.ஏ அனுமதி பெறுகிறது – மனிகண்ட்ரோல்

Translating…

Last Updated : Aug 13, 2019 11:39 AM IST | Source: PTI

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate tablets in the strengths of 48 mg and 145 mg, Alembic Pharmaceuticals said in a BSE filing.

Representative image

Representative image

Drug firm Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator for Fenofibrate tablets, used to lower cholesterol. The approved product is therapeutically equivalent to the reference listed drug Tricor tablets of AbbVie Inc.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate tablets in the strengths of 48 mg and 145 mg, Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA data, Alembic Pharmaceuticals said Fenofibrate tablets has an estimated market size of USD 94 million for twelve months ending December 2018.

Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

It is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.

The company currently has a total of 102 ANDA approvals (90 final approvals and 12 tentative approvals) from the USFDA, it added.

Shares of Alembic Pharmaceuticals were trading 1.22 per cent lower at Rs 538.70 apiece on the BSE.

Subscribe to Moneycontrol Pro and gain access to curated markets data, trading recommendations, equity analysis, investment ideas, insights from market gurus and much more. Get Moneycontrol PRO for 1 year at price of 3 months at 289. Use code FREEDOM.

First Published on Aug 13, 2019 11:35 am