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Biovail citalopram ODT approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail's orally disintegrating tablet formulation of Forest's antidepressant Celexa (citalopram) clears FDA Dec. 20 under the 505(b)(2) pathway. The product, which currently has no trade name, had been "approvable" since February 2005. Biovail will have to submit an sNDA if it decides to market citalopram ODT under a brand name. The sponsor has pointed to the formulation's greater prescribing flexibility as an advantage (1Pharmaceutical Approvals Monthly July 2004, In Brief)...
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