Ranbaxy sues over withdrawn US approvals

Ranbaxy – India’s largest generics manufacturer – has sued the US Food and Drug Administration (FDA) after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs: Roche’s antiviral drug Valcyte (valganciclovir) and AstraZeneca’s heartburn pill Nexium (esomeprazole).

In its lawsuit, launched on 14 November, Ranbaxy says the FDA’s action violates its constitutional rights and has deprived the company of ‘literally hundreds of millions of dollars’ in anticipated revenues.

Ranbaxy also maintains that the FDA issued its decision without prior notice and gave the company no opportunity to comment on the issues raised. Further, Ranbaxy contends that FDA has no power to issue this decision.

However, the FDA argued in its 4 November letter that it had ‘erred’ in tentatively approving the sale of those two generics in 2008. At that time, the agency says, one or more of Ranbaxy’s manufacturing facilities were not compliant with FDA standards.

In fact, last year, Ranbaxy was fined $500 million (£330 million) by FDA for manufacturing failures. The agency has also banned active pharmaceutical ingredients produced at four of the company’s plants in India from being importing into the US.