FDA Signs off on Ivax’s Generic Nexium in Snub to Ranbaxy

The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. 

The agency announced approval of Ivax Pharmaceuticals’ generic version of the blockbuster heartburn therapy in 20 mg and 40 mg doses. The approval adds further drama to the Ranbaxy lawsuit.

Ranbaxy had sought a restraining order barring approval of any other generic versions of Nexium (esomeprazole magnesium) but was rebuffed.

In a court document, the FDA gave notice that it was formally revoking Ranbaxy’s first-filer rights to generic Nexium and granting approval to Ivax. Ranbaxy forfeited its first-filer rights because it failed to obtain tentative approval on the ANDA within 30 months of submission, the agency says.

Ranbaxy’s generic version had been set to hit the market as early as last May, but the GMP and approval flap delayed any Nexium generic for months. Ivax’s is one of at least eight ANDAs filed against Nexium in addition to Ranbaxy’s.

Without Ranbaxy’s first-filer ANDA holding up authorization, the FDA can now sign off on any other application it wants, McGuireWoods attorney Brian Malkin said. Ivax’s approval suggests the FDA is dismissive of Ranbaxy’s chances in the ongoing lawsuit, he adds.

Ranbaxy did not respond to a request for comment by press time. — Bryan Koenig