FDA Roundup: Glenmark Generics Ltd (Corporate) (Company Overview‪)‬

FDA ROUNDUP: Glenmark Generics Ltd., a unit of Glenmark Pharmaceuticals Ltd. (Mumbai, India), received approval for Norethindrone tablets. The tablets are oral contraceptives. The tablets had annual sales of $38 million in the year 2009, Glenmark said. Elsewhere, the agency on Friday approved the first generic version of Sanofi-Aventis SA's (Paris, France) big-selling blood thinner Lovenox, in an action that could offer hints of how the agency will handle generic biotechnology drugs. Lovenox is made from heparin, a complex mixture of sugar chains derived from the intestines of pigs. The question that has confronted the FDA is whether such a complex drug could be copied exactly enough to make a generic form that could be seamlessly substituted for the brand-name product. The agency on Friday said it could, approving a form of the drug developed by Sandoz, the generic division of Novartis AG, using technology from Momenta Pharmaceuticals (Cambridge MA). Momenta, which applied for approval of its drug five years ago, claims its technology can accurately characterize such complex mixtures. Its technology was used to help characterize the contamination of heparin products from China that killed dozens of people in 2007 and 2008. The FDA's approval of Sandoz's generic helped send Momenta shares skyrocketing 89% for the week to $21.70.