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


Schering-Plough answers FDA on Zegerid

This article was originally published in The Tan Sheet

Executive Summary

The proton pump inhibitor's licensee responds to the agency's January complete response letter that detailed concerns about making Zegerid available OTC, according to drug originator Santarus June 9. Zegerid (omeprazole 20 mg/sodium bicarbonate) would likely face an increasingly crowded OTC PPI market, since FDA approved Novartis'/Takeda Pharmaceuticals' yet-to-launch Prevacid 24HR (lansoprazole 15 mg) in May (1"The Tan Sheet" May 18, 2009, p. 3)

You may also be interested in...

Zegerid decision could arrive in December

FDA schedules a December 2009 "action date" for Schering-Plough's Rx-to-OTC switch application for the proton pump inhibitor, Zegerid innovator Santarus says June 23. An FDA spokeswoman declined to say if an action might mean something other than an approval or denial. Schering, which licenses OTC Zegerid (omeprazole 20 mg/sodium bicarbonate), said it responded to FDA concerns about the switch application (1"The Tan Sheet" June 15, 2009, In Brief). If FDA approves a Zegerid switch, the drug would likely be the third branded OTC PPI on the market following Prilosec OTC (omeprazole 20 mg) and Prevacid 24HR (lansoprazole 15 mg). FDA granted Prevacid's switch in May and Novartis aims to ship in 2009 (2"The Tan Sheet" May 18, 2009)

Prevacid Initial Launch Efforts To Focus On Switching Prescription Users

Novartis plans to prioritize converting patients currently treated with prescription Prevacid when the proton pump inhibitor becomes available over-the-counter, rather than winning over Prilosec OTC users, a Novartis executive said

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.





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