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Aripiprazole oral solution is planned to be included in the priority review

 Last Update: 2021-06-30
 Source: Internet
 Author: User

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On June 15th, the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China announced that the aripiprazole oral solution of Sichuan Otsuka Pharmaceutical Co.
, Ltd.
, a subsidiary of Otsuka Pharmaceutical, is suitable for children’s use.
The new varieties, dosage forms and specifications of drugs have been included in the priority review by CDE.
The proposed indications are: irritable symptoms of autism in children and adolescents aged 6-17 years; Tourette syndrome in children and adolescents aged 6-17 years
.

Screenshot source: CDE official website

The aripiprazole oral solution of Sichuan Otsuka Pharmaceutical Co.
, Ltd.
is planned to be included in the priority review.
The proposed indications include autism irritable symptoms and Tourette syndrome
.

According to the Chinese drug clinical trial registration and information disclosure platform, the product has previously completed a multi-center, randomized double-blind, variable-dose, placebo-controlled, phase 3 treatment for children and adolescents with autism in China.

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