Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Prilosec OTC Switch Set For Early 2003 Following FDA “Approvable” Letter

Executive Summary

AstraZeneca's OTC switch for Prilosec (omeprazole) will wait until 2003 after receipt of an "approvable" letter from FDA

You may also be interested in...



Prilosec OTC

AstraZeneca/Procter & Gamble's Prilosec OTC clears FDA June 20 in 28- and 42-count package sizes to limit duration of use to 14 consecutive days and up to three courses per year. P&G plans to launch OTC omeprazole in the fall; approval follows completion of a label comprehension study as requested by FDA in an Aug. 8, 2002 "approvable" letter (1"The Pink Sheet" Aug. 26, 2002, p. 11)...

Prilosec OTC

AstraZeneca/Procter & Gamble's Prilosec OTC clears FDA June 20 in 28- and 42-count package sizes to limit duration of use to 14 consecutive days and up to three courses per year. P&G plans to launch OTC omeprazole in the fall; approval follows completion of a label comprehension study as requested by FDA in an Aug. 8, 2002 "approvable" letter (1"The Pink Sheet" Aug. 26, 2002, p. 11)...

AstraZeneca Crestor Plan: Drop 80 Mg, Submit Lower-Dose Data In Q1

AstraZeneca's updated Crestor NDA will focus on doses of 40 mg and lower following a decision not to seek approval for the 80 mg strength of the cholesterol drug

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS040385

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