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This article was originally published in The Tan Sheet

Executive Summary

FDA requests studies in the pediatric population for Pharmacia & Upjohn's cromolyn sodium nasal spray. If P&U submits studies that are considered sufficient by the agency, Waxman/Hatch marketing exclusivity for the product would be extended by six months from its current expiration on Jan. 3, 2000. The product, which is indicated for both prevention and treatment of allergy symptoms, was approved in January 1997 ("The Tan Sheet" Jan. 13, 1997, p. 1). The original sponsor of the drug was McNeil Consumer Healthcare; P&U acquired the brand in a June 1997 trade with McNeil ("The Tan Sheet" June 9, 1997, p. 2)

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