Sunday, March 23, 2014

Lupin launches Generic Tablets in the US

Pharma  Major Lupin Limited (Lupin) announced  today  that  its  US subsidiary, Lupin Pharmaceuticals Inc. has launched its Niacin Extended‐Release Tablets USP, 500 mg, 750 mg, 1000 mg strengths having received final approval from the United States Food and Drug Administration (FDA) yesterday.
Lupin’s Niacin Extended-Release Tablets USP, 500 mg, 750 mg, 1000 mg strengths are the AB‐rated generic equivalent of AbbVie Inc.’s Niaspan® Tablets 500 mg, 750 mg, 1000 mg and 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 U.S sales of approximately USD 1 billion (IMS MAT Dec, 2013).   Commenting on the approval, Mr. Nilesh Gupta, Managing Director, 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.”