Pink Sheet is part of the Informa Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

Alza stops "Stop and Go"

Executive Summary

FDA objects to Alza "Stop and Go" direct-to-consumer campaign for overactive bladder treatment Ditropan XL (oxybutinin) in July 12 letter to company. According to FDA, the print and broadcast campaign overstated the efficacy for the extended-release oxybutinin formulation because it "fails to prominently disclose that the clinical trials were set up to include only patients who the sponsor knew would have improved symptoms on Ditropan XL because they were known to have had improved symptoms on" oxybutinin or other overactive bladder agents. The agency also objected to the prominent display of the graphic "90%" in TV ads, backed by an audio statement that the drug was shown "to reduce wetting accidents by up to 90% versus 51% for a sugar pill." Alza said it has discontinued the "Stop and Go" campaign and all other promotions with similar messages
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS038278

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

Cancel