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Jubilant Life receives ANDA’s approval for Niacin Extended-Release Tablets USP

15 May 2018 Evaluate

Jubilant Life Sciences’ material wholly owned subsidiary -- Jubilant Pharma, through one of its wholly owned subsidiaries (collectively Jubilant Life) has received Abbreviated New Drug Application (ANDA) final approval for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg, the generic version of Niaspan of AbbVie, which is indicated to reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia thereby reducing the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.

This is the first approval that the company has received from the USFDA during the current financial year. As on March 31, 2018, Jubilant had a total of 94 ANDAs for Oral Solids filed in the US, of which 59 had been approved and 12 Sterile (Injectables & Ophthlamics) filings, of which 10 had been approved.

Jubilant Life Sciences is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions.


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