Drug or technology

Fluoxetine

2 developments in the corpus

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AUG 7, 2026 · PHASE 2 TRIAL

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

ClinicalTrials.gov

This is a Phase 2 interventional trial still recruiting, with no results reported; it is designed to examine neuro-cognitive correlates and treatment response in pediatric anxiety but cannot yet support clinical or practice conclusions.

PreliminaryAttention Bias Modification Training Cognitive Behavioral Therapy NCT00018057

Reported

Estimated enrollment3500

Study phasePHASE 2

Primary outcome measure 1Pediatric Anxiety Rating Scale (PARS), Week…

JUN 17, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Fluoxetine (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to an established generic fluoxetine product; does not contain clinical efficacy or safety data.

Regulatory UpdateSciegen Pharms Fluoxetine

Reported

Approval statusApproved

Approval date2026-06-17

Application numberANDA210935