Ranbaxy bid to regain marketing approval for key generics shot down by federal judge

SINGAPORE--A Ranbaxy Laboratories effort to have two of its drugs returned to the U.S. FDA's marketing-approval list was quashed when a U.S. district judge dismissed the suit at the request of the agency.

The drugs are generic versions of AstraZeneca's ($AZN) Nexium (esomeprazole) for heartburn and Roche's ($RHHBY) Valcyte (valganciclovir), an antiviral. Ranbaxy brought the suit contending the FDA improperly revoked tentative approvals for the drugs after it found noncompliance issues during inspections of two of its production facilities in India.

The agency told the court the temporary approvals were issued by mistake. Ranbaxy responded that the revocation unfairly punished the company, which has been a source of contention for the FDA for several years.

Ranbaxy filed its suit last November, Bloomberg reported.

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