Friday, February 27, 2015

U.S. judge denies Ranbaxy bid to reinstate approvals for Valcyte, Nexium copies

A Ranbaxy office building is pictured in the northern Indian city of Mohali A U.S. federal judge has denied Indian generic drugmaker Ranbaxy Laboratories Ltd's bid to reinstate approvals granted to it to launch the first copies of the heartburn drug Nexium and the antiviral Valcyte, a court document showed. Judge Beryl Howell of the United States District Court for the District of Colombia on Friday also blocked Ranbaxy's plea for a preliminary injunction to halt Teva Pharmaceutical Industries Ltd, Endo International Plc and Dr Reddy's Laboratories Ltd from launching copies of the two drugs. The court decision came after Ranbaxy sued the U.S. Food and Drug Administration in November for pulling approvals that would have allowed the Indian firm to launch the first copies of Roche's Valcyte and AstraZeneca Plc's Nexium. FDA had said its earlier decision granting the approvals was "in error" as Ranbaxy's plants at the time were not compliant with the U.S. regulator's manufacturing quality standards.








via Health News Headlines - Yahoo News http://ift.tt/1ADKZXQ

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