Teva Neuroscience, Inc.: risperidone

Please refer to your new drug application (NDA) dated and received June 17, 2021, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for risperidone extended-release injectable suspension.

TV-46000-CNS-30078 cannot be relied upon based on the information contained in the application.

The application does not contain adequate evidence for the Agency to make an efficacy finding for this new formulation because the doses of IP that provided benefit to patients could not be verified and thus cannot be described in the product label.

In addition, the exposure-response relationship of the safety findings could not be evaluated.

To resolve these deficiencies, submit results of an independent third party audit or poststudy monitoring by the sponsor/Clinical Research Organization (CRO) for all sites and all subjects to establish the extent of IP dosing errors and lack of IP dose documentation and to determine what study data can be relied upon for regulatory decision making.

FDA recommends hat the human-readable expiration date on the drug package label include a year, month, and non-zero day.

FDA recommends that the expiration date appear in YYYY-MMDD format if only numerical characters are used or in YYYYMMM.-DD if alphabetical characters are used to represent the month.

FDA recommends that a slash or a hyphen be used to separate the portions of the expiration date.