(RDY) Dr. Reddy’s Laboratories Earns FDA Approval for Generic
July 14th, 2011Dr. Reddy’s Laboratories (RDY) delivered yet another positive momentum within a week, as the US Food and Drug Administration (FDA) approved fondaparinux sodium injection, the company’s bioequivalent generic version of Arixtra. The drug is currently marketed by GlaxoSmithKline plc (GSK) for preventing deep vein thrombosis (DVT) in adults who are undergoing hip fracture, hip replacement, or knee replacement surgery.
Dr. Reddy’s received final approval from the FDA for the 2.5 mg/ 0.5 mL, 5.0 mg/ 0.4 mL, 7.5 mg/ 0.6 mL and 10 mg/ 0.8 mL doses of fondaparinux sodium injection.
Dr. Reddy’s will be manufacturing the generic version under license using a patented process that is developed by Australia based Alchemia Limited. The current approval comes close on the heels of the US launch of the generic version of Novartis AG’s (NVS) blood pressure drug, Lotrel.
Moreover, last month, Dr Reddy’s had announced the launch of its generic version of Johnson & Johnson’s (JNJ) antibiotic drug, Levaquin, in the US. Additionally in June 2011, the company announced the launch of three other generic products in the US. Dr Reddy’s lau
Tags: Fda, Reddy’s Laboratories
We got nothing useful from Bernanke yesterday.