March 3, 2015.
Reuters reports that Ranbaxy's bid to reinstate approvals granted for the launch of the first copies of Roche's heartburn drug Nexium and AstraZeneca's antiviral Valcyte has been denied by a US federal judge. Ranbaxy sued FDA in November 2014 for pulling approvals that would have allowed it to launch the copies.
Judge Beryl Howell of the District Court for DC also repoertedly blocked Ranbaxy's call for a preliminary injunction to halt Teva, Endo International, and Dr Reddy's Laboratories from launching copies of the two drugs.
FDA said its earlier decision granting Ranbaxy the approvals was made "in error" as the company's plants were not compliant with the U.S. regulator's manufacturing quality standards.