Axid AR exclusivity
This article was originally published in The Tan Sheet
Executive Summary
Three years of marketing exclusivity awarded to Whitehall-Robins' H2 antagonist (nizatidine) for new heartburn treatment indication, granted by FDA April 1 ("The Tan Sheet" April 6, p. 1). Exclusivity for the product extends to April 1, 2001. New labeling directions approved concurrently advise consumers to take the product "right before eating or up to 60 minutes before consuming" heartburn-inducing food -- a product feature that may be highlighted as an advantage versus other acid blockers on the market when OTC nizatidine is relaunched...