Ranbaxy sues US FDA over revoking drug approvals

In a reversal of roles, Ranbaxy Laboratories Ltd, which has all the time been subjected to regulatory action by the US Food and Drug Administration (FDA), has now sued the US regulator for revoking approvals granted to it for launching generic equivalents of AstraZeneca Plc's heartburn pill Nexium and Roche AG's antiviral Valcyte.

FDA, on 6 November 2014, withdrew the previously granted tentative marketing approvals for Ranbaxy's anti-ulcer drug Nexium and HIV infection drug Valcyte.

The FDA told Ranbaxy that its decisions to grant the company tentative approvals for marketing copies of two drugs in the US were ''in error.'' FDA has determined that Ranbaxy's ANDAs for Nexium and Valcyte did not have any data integrity issues and that its original decisions granting tentative approvals were in error because of the compliance status of the facilities at the time of tentative approvals. 

Ranbaxy also lost its six-month market exclusivity for its ANDAs (abbreviated new drug application) for Valycyte and probably for Nexium's generic copy in the US.

Analysts estimate generic Nexium to have contributed about $150 million to Ranbaxy's revenue in the first six months of market exclusivity and Valcyte to bring in revenues of $40 million to $50 million.

Reports said FDA is under pressure from other generic applicants on account of a five-month delay in Ranbaxy's launch of its version of Nexium.

FDA is reported to have 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 period on the launch of the drugs has ended.

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

"FDA has no power to correct an alleged mistake it made six years ago," Reuters quoted from Ranbaxy's suit filed on 14 November.

Ranbaxy, which is being acquired by local rival Sun Pharmaceutical Industries Ltd for $3.2 billion, has been hit by a series of regulatory sanctions in the past year for alleged quality issues related to production practices at its Indian plants.