NAPROXEN RX-TO-OTC SWITCH APPLICATION FINAL FDA REVIEW

Executive Summary

NAPROXEN RX-TO-OTC SWITCH APPLICATION FINAL FDA REVIEW is understood to include a careful once-over of & the key issues by the commissioner's office. Recognizing the sensitivities of an FDA override of the rejection of the naproxen sodium switch by a joint advisory committee, FDA Commissioner Kessler has asked that "option" papers be prepared relating the concerns raised by the committee. The decision to reconsider some of the implications of the naproxen switch is a reasonable precaution given the high-profile nature of the application and the 7-4 rejection of the switch at a joint meeting of FDA's Nonprescription Drugs and Arthritis Advisory Committees in June ("The Pink Sheet" June 7, p. 6). Some of the concerns raised by committee members apparently have been worked out by FDA and the switch application sponsors, Syntex and Procter & Gamble. In a presentation to the Nonprescription Drugs and Arthritis Advisory Committees in September, Office of OTC Drug Evaluation Director Michael Weintraub said Syntex had agreed to reduce its proposed maximum daily dose of OTC naproxen sodium from 800 mg to 600 mg and the dosing interval would be lengthened from one tablet every six-to- 12 hours to one tablet every eight-to-12 hours ("The Pink Sheet" Sept. 13, p. 9).