Jubilant Arm Gets Approval for Niacin ER Tab | CORPORATE ETHOS

Jubilant Arm Gets Approval for Niacin ER Tab

By: | May 15, 2018
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May 15: Jubilant Life Sciences Ltd, an integrated global pharmaceutical and life sciences company, on Tuesday announced that Jubilant Pharma Ltd, a material wholly owned subsidiary of the company, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for its Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg.

According to the company, the product is 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 we have 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,” the company said.