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# FDA Draft Guidance on Risperdal Bioequivalence Studies
- URL: https://www.fdaweb.com/fda-draft-guidance-on-risperdal-bioequivalence-studies/
- Published: 2016-08-29T12:00:00.000Z
- Updated: 2026-09-14T21:27:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136632

FDA has posted a draft guidance on [Bioequivalence Recommendations for Risperidone](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201272.pdf?ref=fdaweb.com) that outlines recommended bioequivalence testing for ANDA sponsors seeking approval for a generic copy of Jannsen’s antipsychotic Risperdal. The document recommends an *in vitro* drug release study and an *in vivo* two-period, crossover steady-state study. The *in vivo* study calls for male and nonpregnant female patients with schizophrenia or bipolar I disorder who are already receiving a stable regimen of risperidone long-acting injection via the intramuscular route. “FDA recommends that studies not be conducted using healthy subjects or patients on a different antipsychotic treatment,” the guidance says.