Lupin gets USFDA nod for Atorvastatin Calcium tablets to lower cholesterol

Atorvastatin Calcium tablets are indicated to lower cholesterol in blood for adults and children over 10 years of age, Lupin said. It works by reducing the amount of cholesterol made by the liver.

Mumbai: Drug firm Lupin recently said it has received approval from the US health regulator to market its generic Atorvastatin Calcium tablets, used for lowering cholesterol, in the American market.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Atorvastatin Calcium tablets in the strengths of 10 mg, 20 mg, 40 mg, and 80 mg, Lupin said in a filing to the BSE.

Also Read: Lupin, Natco receives USFDA nod for Imatinib Mesylate tablets

The product is a generic version of Pfizer Inc's Lipitor tablets in the same strengths, it added. Atorvastatin was patented in 1986 and approved for medical use in the United States in 1996.

The tablets are indicated to lower cholesterol in blood for adults and children over 10 years of age, Lupin said. It works by reducing the amount of cholesterol made by the liver.

Also Read: Lupin posts Q3 loss of Rs 152 crore on litigation over Perindopril

Atorvastatin is also prescribed to lower the risk for heart attack, stroke in patients with cardiovascular diseases, diabetes and other risk factors such as eye problems, kidney diseases or high blood pressure, it added.

According to IQVIA MAT December 2018 data, Atorvastatin Calcium tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg had annual sales of around USD 696 million in the US, it said.

Lupin develops and delivers a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a position in the Anti-TB segment.

Also Read: Relief to Lupin: High court removes ban its diabetes drug Gluconorm P 30