FDA rejects AstraZeneca move on generic Seroquel

Published November 20, 2014

Regulators have rejected a move by AstraZeneca that could have delayed the entry of generic versions of its top-selling antipsychotic Seroquel onto the U.S. market later this month.

Britain's second biggest drugmaker said on Friday the Food and Drug Administration had denied its Citizen Petitions requesting the agency withhold finally approving any generic with labeling that did not have certain warning language required for its branded version.

Generic copies of the original instant-release form of Seroquel, or quetiapine, are due to hit the market on March 26 when AstraZeneca's patent expires.

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