HBW Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

Petitions Denied For ‘Pharmacist Category’ Nonprescription Viagra, Lipitor, Chantix

This article was originally published in The Tan Sheet

Executive Summary

The petitioner offers no evidence to support establishing a “Pharmacists Category of Drugs Behind the Counter” status for nonprescription sales with continued Rx distribution of Viagra, Lipitor, Narcan and Chantix, CDER Director Woodcock says in rejecting a petition on each drug.

You may also be interested in...



Norway Model Offers Key To Unlock More Complex Switches

Norway's move to encourage more innovative Rx-to-OTC switches has begun to bear fruit with the recent reclassification of Pfizer's Viagra. The country's decision to introduce a new non-prescription drug category to promote switching can be used as a model for securing a new wave of more complex switches elsewhere around the world.

Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway

Pfizer has taken the first steps towards turning its Viagra erectile dysfunction treatment into a pan-European OTC brand by taking advantage of Norway's new "non-prescription medicines with guidance" category to secure the Rx-to-OTC switch of the product. Norway will be the second European market where Viagra is available OTC after the UK switched the drug in 2017.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL005491

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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