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Bristol/Otsuka To Submit Abilify Long-Term Efficacy sNDA As Phase IV

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Otsuka/Bristol-Myers Squibb are required to submit an NDA supplement before the end of 2002 on long-term efficacy of its schizophrenia drug Abilify

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Bristol Revisiting Abilify Bipolar Mania Indication, With Filing By Year-End

Bristol-Myers Squibb and Otsuka will take their second stab at an Abilify indication for bipolar mania via an sNDA submission before the end of 2003.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

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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