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19 July, 2018 20:57 IST
Jubilant Life Sciences gets final nod for Niacin ER tablets
Source: IRIS | 15 May, 2018, 03.28PM
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Jubilant Life Sciences, an integrated global Pharmaceutical and Life Sciences Company, has announced that Jubilant Pharma, 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 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, LDLC, 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 (Q,N,C,F)* 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.

Shares of the company declined Rs 20.9, or 2.48%, to trade at Rs 822.65. The total volume of shares traded was 29,580 at the BSE (3.13 p.m., Tuesday).



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