Pediatric exclusivity
This article was originally published in The Tan Sheet
Executive Summary
Deadline for written comments on the pediatric exclusivity program is June 5, FDA announces in a Federal Register notice May 5. The agency must report to Congress by Jan. 1 on the program's effectiveness in improving information about important pediatric uses for approved drugs, adequacy of the pediatric exclusivity incentive, economic impact and modification suggestions. On the OTC front, Pharmacia's NasalCrom (cromolyn sodium) has been granted pediatric exclusivity, extending the nasal spray's marketing exclusivity until July 3. The firm submitted data to FDA on safety, tolerability and efficacy in children aged two and older; the product is approved for use in children six and older
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