Sun Pharmaceutical gets US FDA approval for generic anti-cholesterol tablet

Sun Pharmaceutical Industries Ltd, one of India’s top pharmaceutical companies, on Tuesday announced that one of its subsidiaries has received final approval from US Food and Drug Administration (US FDA) for its generic version of Zetia 10 mg tablets — an anti-cholesterol drug that selectively inhibits the intestinal absorption of cholesterol and related phytosterols.

The company revealed the information about approval of its Abbreviated New Drug Application (ANDA) for generic ezetimibe tablets in a BSE filing.

According to experts, Zetia tablets by Merck — the world’s oldest pharmaceutical and chemical company — is taken along with food for the reduction of elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, and non high-density lipoprotein cholesterol in patients with abnormally elevated levels of any or all lipids or lipoproteins in the blood.

The drug registered an annual sales of approximately $2.7 billion in the US till April 2017.

The US is an important market for top Indian pharmaceutical companies, including Sun Pharma, which has 42 manufacturing facilities spread across six continents.

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