Ranbaxy sues FDA over drugs revoke

Indian drug maker Ranbaxy Laboratories has sued the US Food and Drug Administration (FDA) and claimed it wrongfully revoked a previous approval for two new drugs.

Ranbaxy is disputing the FDA’s decision to revoke the permission it gave it to launch generic versions of AstraZeneca's heartburn pill Nexium (esomeprazole) and Roche's antiviral drug Valcyte (valganciclovir hydrochloride).

In a lawsuit filed at the US District Court for the District of Columbia, Haryana-based Ranbaxy said the FDA’s move violated constitutional rights.

The FDA had told Ranbaxy earlier this month that its 2008 decision to grant the company tentative approvals for the drugs was made "in error" after it found that the Indian company’s manufacturing plants at the time were not compliant with FDA quality standards.

The FDA also revoked Ranbaxy’s 180-day period to exclusively sell generic drug Valcyte.

Ranbaxy claimed the FDA’s move wrongfully punished it for manufacturing deficiencies found at two of its facilities in 2006 and 2008.

“FDA has no power to correct an alleged ‘mistake’ it made six years ago,” Ranbaxy said in its complaint, filed on November 14.

“The agency issued its decision with no prior notice to Ranbaxy. It gave Ranbaxy no opportunity to comment on the issues raised. And, the agency had no power to issue its decision,” the lawsuit added.

Ranbaxy and the FDA did not immediately respond to a request for comment.