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

Merck's NDA For A Pill That Combines Zetia And Lipitor Is Bounced By FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Citing a need for more data, the agency refuses to file an NDA for a pill combining ezetimibe (Zetia) and atorvastatin (Pfizer's Lipitor).

You may also be interested in...



UPDATED: Zetia/Lipitor Combo’s Ongoing Clinical Equivalence Trials May Address FDA’s Data Request, Merck Says

FDA did not accept the company’s bioequivalence arguments supporting a fixed-dose combination of ezetimibe and atorvastatin. Merck believes new data that are expected to be available later this year may address the agency’s “complete response” letter.

Zetia/Lipitor Combo’s Ongoing Clinical Equivalence Trials May Address FDA’s Data Request, Merck Says

FDA did not accept the company’s bioequivalence arguments supporting a fixed-dose combination of ezetimibe and atorvastatin. Merck believes new data that are expected to be available later this year may address the agency’s “complete response” letter.

Gilead's Positive Phase II Data On Quad Pill For HIV Eases Analysts Concerns

The four-drug combination pill for HIV has significant sales potential, and will be a mainstay for Gilead to protect its leadership in the market, but with two novel components there is still much work to be done.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068784

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