FDA asks Teva for further information on Huntington disease drug
Teva Pharmaceutical Industries (NYSE: TEVA) has been asked to provide more information on its New Drug Application for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD) by the US Food and Drug Administration.
The Israeli drugmaker received a Complete Response Letter from the regulator as it considers what is the first deuterated product to be reviewed by the FDA. The letter asks Teva to examine blood levels of certain metabolites.
These metabolites are not novel and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested.
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