Aldurazyme complete response
Executive Summary
Biomarin's Aldurazyme (laronidase) receives a complete response letter Jan. 28. FDA asked for more information on "postmarketing commitments, final product labeling, and completion of the manufacturing inspections process," Biomarin said. FDA completed its pre-approval inspections, and no further inspections are scheduled. The company expects Aldurazyme's postmarketing commitments to follow the Endocrinologic & Metabolic Drugs Advisory Committee recommendations of antibody formation monitoring. The committee unanimously recommended FDA approve Aldurazyme as treatment for mucopolysaccharidosis I (1"The Pink Sheet" Jan. 20, p. 18)...