Ranbaxy sues FDA over revoking approvals for Nexium, Valcyte copies

Reuters MUMBAI | Updated on March 12, 2018 Published on November 18, 2014

A Ranbaxy office building is pictured in the northern Indian city of Mohali in this May 14, 2013 file photo. The U.S. Food and Drug Administration has banned products from a fourth plant in Toansa run by Indian drugmaker Ranbaxy Laboratories from entering the United States due to manufacturing violations, sending its stock down nearly 20 percent on January 24, 2014. REUTERS/Ajay Verma/Files (INDIA - Tags: HEALTH BUSINESS DRUGS SOCIETY POLITICS)

Ranbaxy Laboratories Ltd has sued the US Food and Drug Administration (FDA) for revoking approvals granted to the Indian firm to launch copies of two drugs including AstraZeneca Plc's heartburn pill Nexium, court documents showed.

The FDA told Ranbaxy this month that it believed its decisions to grant the company tentative approvals for copies of Nexium and Roche AG's antiviral Valcyte were "in error", after it found that Ranbaxy's plants at the time were not compliant with the FDA's manufacturing quality standards.

The agency also stripped Ranbaxy of six-month market exclusivity on the launch of generic Valcyte.

In the suit filed in the District Court for the District of Columbia, Ranbaxy said the FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law."

"FDA has no power to correct an alleged mistake it made six years ago," Ranbaxy said in the court filing dated November 14 and seen by Reuters on Tuesday.

Ranbaxy, which is being acquired by larger local rival Sun Pharmaceutical Industries Ltd for $3.2 billion, has been hit by a series of regulatory sanctions in the past year due to poor production practices at its India-based plants.

The company, which was expected to hugely benefit from the launch of the generic versions of the two drugs, has said it was working on resolving issues at the India plants, all of which are banned from exporting to the US, its largest market.

Ranbaxy did not immediately respond to a request for comment, while a spokeswoman for FDA did not reply to an e-mail seeking comment outside of US business hours.

Analysts had expected generic Nexium to contribute about $150 million to Ranbaxy's revenue in the first six months of market exclusivity, while Valcyte was expected to bring in $40 million to $50 million.

After pulling Ranbaxy's tentative approvals, the FDA granted final approval to another Indian generic drugmaker Dr Reddy's Laboratories Ltd and US-based Endo International Plc to launch copies of Valcyte.

Ranbaxy in the lawsuit also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until its six-month exclusive periods on the launch of the drugs has ended.

Published on November 18, 2014

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