Requests that the FDA Refuse to file Otsuka Pharmaceuticals’ pending NDA for centanafadine, once daily sustained release capsules for treatment of ADHD, unless such application contains and addresses, including in its abuse potential assessment under 21 C.F.R. § 314.50(d)(vii), the results of a human abuse potential (HAP) study conducted on the formulation for which approval is sought. | Federal Regulations · Congress.wiki