Ranbaxy sues FDA over revoking approvals for Nexium, Valcyte copies

November 18, 2014 1:15 PM

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MUMBAI (Reuters) - Ranbaxy Laboratories Ltd has sued the U.S. 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.

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