Glaxo Beconase growth suppression is safety concern in Rx labeling.
This article was originally published in The Tan Sheet
Executive Summary
BECONASE SWITCH NOT BEING PURSUED BY GLAXO; the company is re-evaluating its options for the inhaled corticosteroid asthma/allergy treatment. Concern over the potential of the beclomethasone dipropionate .042% nasal spray to retard the growth of children and adolescents recently prompted the addition of a warning to labeling of the prescription product. Consideration of Glaxo Wellcome's Rx-to-OTC switch application for Beconase by FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees was canceled at the company's request in September ("The Tan Sheet" Sept. 8, in Brief).