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Ecopipam NDA accepted with priority review for pediatric Tourette syndrome

Sponsor
Teva Pharmaceuticals $TEVA
Drug
ecopipam
Indication
pediatric Tourette syndrome
More on Teva Pharmaceuticals ↗ Google News

FDA accepted Teva's NDA and granted priority review for ecopipam, a first-in-class therapy for pediatric Tourette syndrome.

What this means

Ecopipam is an oral pill that works by blocking dopamine, a brain chemical involved in involuntary tics. Today the FDA accepted Teva's application for the drug's use in children with Tourette syndrome and will grant it a faster, six-month review. The agency recommends healthcare professionals "inform patients and their caregivers of the potential for suicidality and depression and advise them to watch for the emergence or worsening of these symptoms.

Read original at drugs.com ↗
Topic NDA acceptance