Jubilant Life Sciences Ltd recently announced that it has received the final approval from USFDA for its generic Niacin extended-release tablets used for controlling cholesterol levels.
According to the company statement, “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.”
These are the generic equivalent of AbbVie's Niaspan, which is indicated to reduce elevated high-density lipoprotein 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. This is the first approval that we have received from the USFDA during the current financial year”, the statement added.
