(Reuters) - 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.
Looking beyond the spin of Big Pharma PR. But encouraging gossip. Come in and confide, you know you want to! “I’ll publish right or wrong. Fools are my theme, let satire be my song.” Email: jackfriday2011(at)hotmail.co.uk
Friday, March 09, 2012
FDA rejects AstraZeneca move on generic Seroquel | Reuters
via reuters.com
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