MUMBAI, Feb 28 (Reuters) - A U.S. federal judge has deniedIndian generic drugmaker Ranbaxy Laboratories Ltd's bid to reinstate approvals granted to it to launch the firstcopies of the heartburn drug Nexium and the antiviral Valcyte, acourt document showed.
Judge Beryl Howell of the United States District Court forthe District of Colombia on Friday also blocked Ranbaxy's pleafor a preliminary injunction to halt Teva PharmaceuticalIndustries Ltd, Endo International Plc and DrReddy's Laboratories Ltd from launching copies of thetwo drugs.
The court decision came after Ranbaxy sued the U.S. Food andDrug Administration in November for pulling approvals that wouldhave allowed the Indian firm to launch the first copies ofRoche's Valcyte and AstraZeneca Plc's Nexium.
Launching the first generic copies of the drugs would havegiven Ranbaxy six months of exclusivity on the market.
FDA had said its earlier decision granting the approvals was"in error" as Ranbaxy's plants at the time were not compliantwith the U.S. regulator's manufacturing quality standards.
Ranbaxy, which is being acquired by larger rival SunPharmaceutical Industries Ltd, did not immediatelyrespond to a request seeking comment on Saturday.
The company, which has been hit by a series of regulatorysanctions in the past year due to poor production practices atits India-based plants, was expected to hugely benefit from thelaunch of Valcyte and Nexium copies.
Ranbaxy has previously said it was working on resolvingissues at its India plants, all of which are banned fromexporting to the United States, its largest market. (Reporting by Zeba Siddiqui in Mumbai; Editing by SumeetChatterjee and Michael Perry)
Astrazeneca (AZN)
