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

Reuters Health Information: U.S. judge denies Ranbaxy bid to reinstate approvals for Valcyte, Nexium copies

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

Last Updated: 2015-03-02

By Reuters Staff

MUMBAI (Reuters) - 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 (esomeprazole) and the antiviral Valcyte (valganciclovir), 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.

Launching the first generic copies of the drugs would have given 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 compliant with the U.S. regulator's manufacturing quality standards.

Ranbaxy, which is being acquired by larger rival Sun Pharmaceutical Industries Ltd, did not immediately respond to a request seeking comment on Saturday.

The company, which has been hit by a series of regulatory sanctions in the past year due to poor production practices at its India-based plants, was expected to hugely benefit from the launch of Valcyte and Nexium copies.

Ranbaxy has previously said it was working on resolving issues at its India plants, all of which are banned from exporting to the United States, its largest market.

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