Business · 29/03/2005Updated: 10/17/2026 · 1 min read

FDA Refers KEMSTRO (Baclofen) and DROXIA (Hydroxyurea) for Pediatric Studies

Summary

The FDA has referred KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the Foundation for the National Institutes of Health for pediatric studies, as mandated by the Best Pharmaceuticals for Children Act (BCPA), following referrals on September 1, 2004, and October 20, 2004, respectively.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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