As Generic Seroquel Launches, Questions Remain on Labeling, AstraZeneca’s Next Steps

A bevy of generic manufacturers have launched or plan to launch generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel in the same week a federal judge dismissed the drugmaker’s attempts to block competition.

AstraZeneca had argued that generic-drug makers need warnings for high blood sugar and diabetes in their labeling but the required data tables are protected by exclusivity until December 2012.

It wasn’t clear March 28 what the generics’ warning labels would carry, as the FDA hadn’t posted the ANDAs’ approval letters online. AstraZeneca twice petitioned the agency asking it not to approve generic Seroquel based on the protected data in the FDA-required warnings.

With the FDA punting on its petitions, AstraZeneca had asked a Washington, D.C., federal court for an injunction on generic Seroquel, a move the court denied citing no final approval.

Labeling remains one of the most intense negotiations the drug industry has with the FDA. Each October, an elite group of drug and biologic industry executives, FDA officials and industry attorneys convene to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

Don’t wait around a miss the opportunity to be a part of this debate, register today for the Third Annual Pharmaceutical Labeling Summit The Intersection of Policy, Process and Patients on Oct. 16 and 17 that will send you home with the knowledge you need to stay on top of the labeling game.