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

UsernamePublicRestriction
UsernamePublicRestriction

Zantac 75 Efferdose petition

This article was originally published in The Tan Sheet

Executive Summary

Regulatory strategist Thomas Blake, PhD, asks FDA whether Warner-Lambert is not marketing Zantac 75 Efferdose due to "reasons of safety or efficacy" in a Feb. 29 citizen petition. The effervescent ranitidine 75 mg product initially was approved for heartburn treatment in February 1998 and was granted a prevention indication in March 1999. Warner-Lambert says the status of the product is unclear

You may also be interested in...



Zantac 75 Efferdose

Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals. Although the OTC was approved in February 1998 for heartburn treatment and received a prevention indication in March 1999, W-L has never marketed it. Responding to a citizen petition filed in February by regulatory strategist Thomas Blake, PhD, FDA determines "never marketing an approved drug product is equivalent to withdrawing the drug product from sale" (1"The Tan Sheet" March 13, In Brief). The agency will keep the product in the Orange Book's "Discontinued Drug Product List"

Zantac 75 Efferdose

Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals. Although the OTC was approved in February 1998 for heartburn treatment and received a prevention indication in March 1999, W-L has never marketed it. Responding to a citizen petition filed in February by regulatory strategist Thomas Blake, PhD, FDA determines "never marketing an approved drug product is equivalent to withdrawing the drug product from sale" (1"The Tan Sheet" March 13, In Brief). The agency will keep the product in the Orange Book's "Discontinued Drug Product List"

Zantac 75 Efferdose

Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals. Although the OTC was approved in February 1998 for heartburn treatment and received a prevention indication in March 1999, W-L has never marketed it. Responding to a citizen petition filed in February by regulatory strategist Thomas Blake, PhD, FDA determines "never marketing an approved drug product is equivalent to withdrawing the drug product from sale" (1"The Tan Sheet" March 13, In Brief). The agency will keep the product in the Orange Book's "Discontinued Drug Product List"

Topics

UsernamePublicRestriction

Register

PS090974

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