FDA Mulls Clearing Abilify Rival Based On Single Trial
By Jeff Overley (February 4, 2015, 6:09 PM EST) -- The U.S. Food and Drug Administration on Wednesday disclosed that it is considering whether to approve a competing version of blockbuster antipsychotic Abilify on the basis of a single clinical trial, a move that could have important implications for drugmaker profits.
The disclosure came in response to a citizen petition in which Abilify manufacturer Otsuka Pharmaceutical Co. Ltd. last year urged the FDA not accept or approve an application for a competing new drug from Alkermes PLC. Otsuka's rationale is that Alkermes only conducted a single stage III clinical trial and that its product doesn't qualify for any of the exceptions...
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