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Biovail orally disintegrating citalopram

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail is describing its rapidly dissolving tablet formulation of Forest's antidepressant Celexa (citalopram) as offering physicians greater prescribing flexibility. FDA accepted the 505(b)(2) NDA June 13; the application was submitted April 13, putting the user fee deadline in February. The formulation employs Biovail's FlashDose technology. Forest expects multiple citalopram generics to hit the market in January. The firm is focusing on switching Celexa patients to the follow-on compound Lexapro (escitalopram)..

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