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Risperdal, Seroquel sNDAs Submitted For Acute Mania; Other sNDAs Filed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca and Johnson & Johnson are both pursuing acute mania indications for their atypical antipsychotic agents via supplemental NDAs submitted in December.

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Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals






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