Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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).

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts