Referral of KEMSTRO (Baclofen) and DROXIA (Hydroxyurea) for the Conduct of Pediatric Studies

Streszczenie

The Food and Drug Administration (FDA) is announcing the referral of KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the Foundation for the National Institutes of Health (the Foundation) for the conduct of pediatric studies. FDA referred KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the Foundation on September 1, 2004, and October 20, 2004, respectively. FDA is publishing this notice of the referrals in accordance with the Best Pharmaceuticals for Children Act (BCPA).