Alembic Pharmaceuticals Limited 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 (HDLC) 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. 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 2018 according to IQVIA.
Alembic now has a total of 102 ANDA approvals (90 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.538.5 as compared to the previous close of Rs. 529.95. The total number of shares traded during the day was 5901 in over 482 trades.
The stock hit an intraday high of Rs. 549 and intraday low of 531.05. The net turnover during the day was Rs. 3193857.