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BioWorld - Thursday, November 13, 2025
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Home » CRL halts Otsuka’s drive for a PTSD treatment
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CRL halts Otsuka’s drive for a PTSD treatment

Sep. 23, 2025
By Lee Landenberger
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The first new U.S. FDA-approved therapeutic option for PTSD in more than 20 years will have to wait. A supplemental NDA seeking approval of Rexulti (brexpiprazole) combined with sertraline, filed by one of Japan’s biggest pharmas, Otsuka Pharmaceutical Co. Ltd., received a complete response letter (CRL) from the agency.
BioWorld BioWorld Asia Regulatory Neurology/psychiatric Bispecific antibody Asia-Pacific Japan U.S. FDA

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