Lupin launches generic Niaspan in USA

Indian drugmaker Lupin (LOPN: BO) says that its US subsidiary has launched its niacin extended-release tablets USP, 500mg, 750mg, 1,000mg strengths having received final approval from the US Food and Drug Administration.

Lupin’s product is the AB-rated generic equivalent of AbbVie (NYSE: ABBV) Niaspan tablets in the same dosages used with diet to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. Niaspan tablets had annual US sales of around $1 billion in the 12 months ended December 2013, according to IMS data quoted by Lupin.

Commenting on the approval Vinita Gupta, chief executive of Lupin Limited, said: “We are happy to launch this product having received approval from the FDA yesterday. The launch bears testimony to our commitment to serving our customers and patients by bringing high quality, affordable medicines to the market.”