New Delhi:Jubilant Life Sciences Ltd on Tuesday said it has received the final approval from USFDA for its generic Niacin extended-release tablets used for controlling cholesterol levels.
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.
The drug helps reduce the risk of recurrent nonfatal myocardial infarction (heart attack) in patients with a history heart disease and hyperlipidemia, the statement added. “This is the first approval that we have received from the USFDA during the current financial year," it said.
As on 31 March, 2018, Jubilant had a total of 94 ANDAs for oral solids filed in the US, the company said.