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"Teva announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). This is the first deuterated product to be reviewed by the FDA. The FDA has asked Teva to examine blood levels of certain metabolites.", www.dddmag.com
"The FDA has issued a complete response letter regarding the new drug application for deutetrabenazine (SD-809, Teva Pharmaceutical Industries) for the treatment of chorea associated with Huntington disease (HD). The agency has asked Teva to examine blood levels of certain metabolites. No new clinical trials have been requested.", www.managedcaremag.com
"Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd. (TEVA) Tuesday said it received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration regarding the New Drug Application, or NDA, for SD-809 tablets for the treatment of chorea associated Huntington disease or HD.", www.rttnews.com
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