Ranbaxy Sues US FDA For Withdrawing Approval For Its Drugs

Ranbaxy has filed a complaint against the US Food and Drug Administration (FDA) in an American federal court for revoking approvals to market generic versions of patented drugs — Astra Zeneca's anti-ulcer pill Nexium and Roche's anti-viral Valcyte.

In its petition, Ranbaxy said that the FDA had exceeded its jurisdiction by revoking the approvals which were granted a few years ago. Ranbaxy called the FDA's decision "arbitrary, capricious and contrary to law." It added, "FDA has no power to correct an alleged 'mistake' it made six years ago".

FDA had withdrawn its approvals, saying it had made a mistake in granting them. Ranbaxy had sought FDA’s approval for the drugs manufactured at its Paonta Sahib plant, which the FDA had blacklisted in 2008.

The FDA, while revoking its approvals, said, “Ranbaxy forfeited its eligibility for 180-day exclusivity for generic Valcyte but was silent on whether the company had also surrendered its exclusivity rights for generic Nexium. Ranbaxy in its plea has assumed that its exclusivity for Nexium is most likely to meet a similar fate.”