Ranbaxy blocked from launching generic Nexium, Valcyte

March 6, 2015

A federal judge recently denied Ranbaxy Laboratories Ltd's attempt to be the first drugmaker to launch generic versions of Nexium and Valcyte.

A federal judge recently denied Ranbaxy Laboratories Ltd's attempt to be the first drugmaker to launch generic versions of Nexium and Valcyte.

Judge Beryl Howell of the United States District Court for the District of Colombia also denied Ranbaxy’s attempt to stop Teva Pharmaceutical Industries Ltd, Endo International Plc, and Dr Reddy's Laboratories Ltd from launching generic versions of the two drugs.

Report: Ranbaxy faked documents to get FDA approvals

Last November, Ranbaxy sued the FDA after the agency revoked the approvals it had granted the Indian drugmaker to produce the first generic versions of Roche's Valcyte and AstraZeneca Plc's Nexium. Had the FDA approval remained in place, Ranbaxy would have had six months of exclusivity in producing the generic versions of the two popular drugs.

FDA officials said the agency should not have granted the earlier approval because Ranbaxy’s plants were not in compliance with U.S. manufacturing quality standards.

FDA investigations of Ranbaxy found the company had a "persistent ... pattern" of submitting "untrue statements." Investigators also found more than 1,600 data errors for 15 generic Abbreviated New Drug Application’s from Ranbaxy. Eventually, FDA deemed Ranbaxy’s drugs potentially unsafe and illegal to sell. All of Ranbaxy’s India plants are banned from exporting drugs to the United States.

 

In 2013, Ranbaxy pled guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of its manufacturing facilities in India. Ranbaxy paid a $150 million criminal fine and $350 million to settle related civil claims.

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Another Ranbaxy facility stopped from making APIs for U.S.