U.S. FDA Accepts Teva's New Drug Application (NDA) and Grants Priority Review for ...

The U.S. FDA has accepted Teva's New Drug Application for ecopipam, a first-in-class dopamine D1 receptor antagonist for treating pediatric Tourette syndrome, granting it priority review with a PDUFA target date in early 2027. This therapy could become the first new treatment option for pediatric Tourette syndrome in over a decade, addressing significant unmet needs in this patient population.

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