The approval granted by the US Food and Drug Administration (USFDA) to the company's wholly-owned arm Jubilant Pharma Ltd, is for multiple strengths of Niacin extended-release tablets of 500 mg, 750 mg, and 1,000 mg, the company said in a statement.
These are the generic equivalent of AbbVie's Niaspan, which is indicated to reduce elevated high-density lipoprotein (known as bad cholesterol), among others while increasing HDL-C (good cholesterol) in patients with primary hyperlipidemia and mixed dyslipidemia.
"This is the first approval that we have received from the USFDA during the current financial year," it said.
As on March 31, 2018, Jubilant had a total of 94 ANDAs for oral solids filed in the US, the company said.
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