US court refuses Ranbaxy appeal to block ANDA nod for 2 drugs

Ranbaxy had sued US FDA over revoking an approval to sell generic versions of Nexium and Valcyte in US market

Drug firm Ranbaxy Laboratories today said the DC Federal Court in the US has not granted the company temporary restraining order to block the US health regulator from approving other ANDAs for generic versions of digestive disorder medicine Nexium and anti-viral Valcyte.

"The Court has not granted temporary restraining order to block FDA approval for other Abbreviated New Drug Applications (ANDAs) for generic version of Nexium and Valganciclovir," Ranbaxy Laboratories said in a filing to the BSE.

However, the court ordered the parties to the suit to agree upon a schedule for filing additional legal briefs, addressing Ranbaxy's request for a preliminary injunction by November 21, 2014, it added.

Ranbaxy Laboratories had sued US FDA over revoking an approval to sell generic versions of Nexium and Valcyte in the US market.

It had also sought restraining the approval given by the US FDA to Dr Reddy's Laboratories and Endo Pharmaceuticals from launching generics of Valcyte.

While revoking Ranbaxy's approval for the two drugs, the US FDA cited adverse compliance status of Ranbaxy's Paonta and Dewas facilities and it was "accordingly... Correcting its mistake and rescinding the tentative approval letters issued regarding these ANDAs."

As per the lawsuit filed in the US District Court of Columbia, the company had sought "immediate judicial review" of a November 4 decision of the US Food and Drug Administration (US FDA) that stripped Ranbaxy of "its statutory rights" and "literally hundreds of millions of dollars in anticipated revenues for certain generic versions of the brand-name drugs Nexium and Valcyte."

Ranbaxy, however, in its suit had said the US FDA "has no power to correct an alleged 'mistake' it made six years ago."

"Nothing in the FDCA permits FDA to revoke the issuance of a tentative approval and even if the agency did have such authority, it was not timely exercised here."

US FDA not only was aware of the relevant facilities' compliance issues at the time it granted tentative approval (TA) to Ranbaxy's ANDAs, but senior FDA officials, including those at the highest levels, considered and determined that those products were eligible for TA despite the known compliance issues at relevant facilities, the company said in its petition.

Shares of Ranbaxy Laboratories were trading 1.10 per cent down at Rs 613.85 per scrip during afternoon session on the BSE.